DRY AMD
NEW Study: A Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of 1.0 Mg Luminate (Alg-1001) As A Treatment For Non-Exudative Macular Degeneration
ClinicalTrials.gov Identifier: NCT03626636
Sponsor: Allegro Ophthalmics, LLC
Purpose: To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration
Design: Randomized, double masked
Number of Patients: 40
Inclusion Criteria: Male or female patients, 50 to 85 years of age at screening visit; Subject has signed the Informed Consent form; Subjects with Non-Exudative AMD having ETDRS BCVA between 33 and 72 letters read (equivalent to 20/40 - 20/200 on Snellen Chart) with the level of vision caused by the non-exudative AMD and no other factor/s; Subjects with symptomatic decrease in visual acuity in the last 12 months; Subjects with combination of areas of RPE disturbances (hyper or hypopigmentation) and/or > 1 large druse(n) (>125 microns) and/or multiple intermediate drusen (62-124 microns) in the macula as confirmed by the central reading center; Subjects with evidence of reasonably well-preserved areas of RPE by clinical examination and well-defined RPE and outer segment ellipsoid line by OCT examination in the central 1 mm of the macula as confirmed by the central reading center. More specifically, reasonable reasonably well- preserved central 1 mm of the macula means: The RPE and outer retinal layers throughout the central 1 mm are intact; No signs of NVAMD such as intraretinal or sub retinal fluid, or sub retinal hyper-reflective material; No serous pigment epithelium detachments >100 microns in height.
Exclusion Criteria: Females who are pregnant, nursing, planning a pregnancy during the study or who are of childbearing potential not using a reliable method of contraception and/or not willing to maintain a reliable method of contraception during their participation in the study. Women of childbearing potential with a positive urine pregnancy test administered at baseline are not eligible to receive study drug. Participation in an investigational drug or device study within 90 days of screening; Subjects with active exudative AMD in the fellow eye; Subjects who had anti-VEGF IVT in either eye in the past 90 days; Subjects with pigment epithelium detachments; Subjects with active exudative AMD; Subjects with any prior retina surgery; Subjects with pathology that could prevent observation and follow-up of macular structures and measurement of BCVA (i.e. advanced primary open angle glaucoma, any stage of normal tension glaucoma and corneal opacification); Subjects that are likely to require cataract surgery in the opinion of the investigator within the study protocol period.
NEW Study: Carbidopa-Levodopa in Dry AMD With Geographic Atrophy
ClinicalTrials.gov Identifier: NCT03451500
Sponsor: Snyder, Robert W., MD, PhD, PC
Purpose: The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due to "wet" (neovascular) AMD. The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Dry AMD and Geographic Atrophy, and measure the effects on visual acuity, area of geographic atrophy and other retinal abnormalities due to "dry" AMD.
Design: randomized, parallel assignment
Number of Patients: 254
Inclusion Criteria: A diagnosis of dry AMD with geographic atrophy in one or both eyes. In patients with geographic atrophy in both eyes, the eye with the larger area of geographic atrophy will be designated eye A and the eye with the smaller area of geographic atrophy will be designated eye B. Normal or dry AMD of any grade in the second eye; Age 50-85 years; Willingness to maintain AREDS vitamin supplements throughout the study, or remain off these supplements for the duration of the study, if not taking them prior to the study; Signed Informed Consent.
Exclusion Criteria: Any previous or current use of L-DOPA containing medication or dopamine agonist medication, or any planned use of any of these agents, except for study medication, during the study; Concurrent use of monoamine oxidase (MAO) inhibitors; Any eye condition, disease, or history of trauma in either eye, which can impair vision, except cataract or cataract surgery; BCVA worse than 20/100 in the eye with better BCVA; Current, or history of, neovascular AMD in either eye; Neurologic conditions which can impair vision; Parkinson's Disease; Significant orthostatic hypotension, defined as a drop in systolic blood pressure, immediately upon changing from the supine to standing position, of >19 mmHg, or a symptomatic drop in systolic blood pressure, immediately upon changing from the supine to standing position; Significant ECG abnormalities, as judged by the Investigator; Estimated glomerular filtration rate (eGFR) <20 ml/min; Liver enzymes >3 X the upper limit of normal; HbA1C >9.0; Any other significant lab abnormalities, as judged by the Investigator. Women of childbearing potential; Known retinal hemorrhage; Subjects who are not fluent in English.
Information: tcfaganmd@gmail.com; rsnyder781@gmail.com
Study: Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02286089
Sponsor: Cell Cure Neurosciences Ltd.
Purpose: The main objective of the study is evaluation of the safety and tolerability of OpRegen - human embryonic stem cell-derived retinal pigment epithelial (RPE)cells. The study will also include initial exploration of the ability of transplanted OpRegen cells to engraft, survive, and moderate disease progression.
Design: No masking, single group
Number of Patients: 24
Inclusion Criteria: Age 50 and older; Diagnosis of dry (non-neovascular) age related macular degeneration in both eyes; Funduscopic findings of dry AMD with progressive geographic atrophy in the macula; Best corrected central visual acuity equal or less than 20/200 in cohorts 1-3 and 20/64-20/250 in cohort 4 in the study eye by ETDRS vision testing; Vision in the non-operated eye must be better than or equal to that in the operated eye; Subjects with sufficiently good health to allow participation in all study-related procedures and complete the study follow up period (medical records); Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care; Blood counts, blood chemistry, coagulation and urinalysis without abnormal significance; Negative for TB (cohort 4), HIV, HBC, and HCV, negative for CMV IgM and EBV IgM; Patients with no history of malignancy (other than a non-melanoma skin cancer). For cancers in remission for more than 5 years enrollment is allowed with concurred documented approval of principal investigator and oncologist prior to enrollment; Willing to defer all future blood and tissue donation; Able to understand and willing to sign informed consent.
Exclusion Criteria: Evidence of neovascular AMD by history, as well as by clinical exam, fluorescein angiography (FA), or ocular coherence tomography (OCT) at baseline in either eye; History or presence of diabetic retinopathy, vascular occlusions, uveitis, Coat's disease, glaucoma, cataract or media opacity preventing posterior pole visualization or any significant ocular disease other than AMD that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome; History of retinal detachment repair in the study eye; Axial myopia greater than -6 diopters; At least 2 months following cataract removal in the study eye and Yttrium Aluminum Garnet (YAG) laser capsulotomy in the study eye in the past 4 weeks and any other ocular surgery in the study eye in the past 3 months prior to implantation; History of cognitive impairments or dementia; Contraindication for systemic immunosuppression; History of any condition other than AMD associated with choroidal neovascularization in the study eye (e.g. pathologic myopia or presumed ocular histoplasmosis); Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk. Female; pregnancy or breastfeeding; Current participation in another clinical study. Past participation (within 6 months) in any clinical study of a drug administered systemically or to the eye. Currently receiving aspirin, aspirin containing products and/or any other coagulation modifying drugs which cannot be discontinued 7 days prior to surgery; History of cancer (other than a non-melanoma skin cancer). For cancers cured more than five years ago, enrollment is allowed with concurred documented approval of principal investigator and oncologist prior to enrollment.
Information: maria@cellcure.co.il; grazag@biotimeinc.com
Study: Safety and Efficacy of IONIS-FB-LRX in up to 120 Patients 55 and Older With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
ClinicalTrials.gov Identifier: NCT03446144
Sponsor: Ionis Pharmaceuticals, Inc.
Purpose: The purpose of this study is to assess the safety and efficacy of IONIS-FB-LRX for up to 120 patients with geographic atrophy secondary to age related macular degeneration.
Design: Randomized, parallel assignment, double masked
Number of Patients: 120
Inclusion Criteria: Must have given written informed consent and be able to comply with study requirements. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile or, if engaged in sexual relations with a female of child bearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent form until at least a period of 13 weeks after the last dose of Study Drug (ISIS 696844 or placebo). Well-demarcated geographic atrophy due to age related macular degeneration.
Exclusion Criteria: Clinically-significant abnormalities in medical history. Diagnosis of primary or secondary immunodeficiencies of B lymphocyte function, splenectomy, glomerulonephritis or history of recurrent meningococcal disease. Diabetes mellitus or thyroid disease unless well controlled for a period of at least 3 months. Clinically-significant abnormalities in screening laboratory values. Unwillingness to be administered, or history of a serious reaction to protocol required vaccines. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B. History or presence of a disease other than AMD in study eye.
Information: patients@ionisph.com
Study: Alpha MSH in Ocular Disease
ClinicalTrials.gov Identifier: NCT03451578
Sponsor: Duke University
Purpose: The purpose of this study is gain a better understanding of a molecule called alpha melanocyte stimulating hormone (alpha MSH) and its potential role in your retinal disease. Alpha MSH has been shown to have an important role in the regulation of ocular immunity in animal models of inflammatory retinal diseases and retinal dystrophies, and there may be a protective effect of alpha MSH. By studying the levels of alpha MSH in your eye, we may better understand its role in advanced dry macular degeneration. By studying the levels of this molecule, we hope to better understand if it may be a good target for future treatment.
Design: Single group, no masking, diagnostic
Number of Patients: 60
Inclusion Criteria: 60 years or older; diagnosis of advanced dry macular degeneration with foveal geographic atrophy; limited vision or blindness (20/100 or worse) in that eye; pseudophakia (prior cataract surgery in that eye).
Information: latoya.greene@duke.edu
Study: Zimura in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02686658
Sponsor: Ophthotech Corporation
Purpose: The objectives of this study are to evaluate the safety and efficacy of intravitreous administration of Zimura when administered in subjects with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 200
Inclusion Criteria: Subjects of either gender aged ≥50 years; diagnosis of Non-foveal GA secondary to dry AMD.
Exclusion Criteria: Evidence of Choroidal Neovascularization (CNV); GA secondary to any condition other than AMD; any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals; any intraocular surgery or thermal laser within three (3) months of trial entry; any prior thermal laser in the macular region, regardless of indication; any ocular or periocular infection in the twelve (12) weeks; previous therapeutic radiation in the region of the study eye; any sign of diabetic retinopathy in either eye.
Information: lillian.vazquez@ophthotech.com
Study: Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
ClinicalTrials.gov Identifier: NCT03295877
Sponsor: Genentech, Inc.
Purpose: This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.
Design: Nonrandomized, Sequential Assignment, No Masking, Treatment
Number of Patients: 44
Inclusion Criteria: Participants aged greater than or equal to (>/=) 50 years. Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in study eye.
Exclusion Criteria: Ocular Exclusion Criteria, Study Eye: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD; previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy; prior treatment with Visudyne, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy. Ocular Exclusion Criteria (Both Eyes): GA in either eye due to causes other than AMD; Evidence of prior or active CNV; Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (ie, ocular or systemic) within the last 6 months.
Information: global-roche-genentech-trials@gene.com
Study: Treatment of Advanced Dry Age Related Macular Degeneration with AAVCAGsCD59
ClinicalTrials.gov Identifier: NCT03144999
Sponsor: Hemera Biosciences
Purpose: To determine the safety of the ocular gene therapy product AAVCAGsCD59 in protecting central vision, by inhibiting the formation of membrane attack complex (MAC). MAC has been linked to an overactive inflammatory cascade that recent evidence associates with dry AMD. This study will evaluate the safety after a single injection of AAVCAGsCD59 administered in an office setting for patients whose enrolled eye has advanced dry AMD with geographic atrophy.
Design: Nonrandomized, Sequential Assignment, No Masking
Number of Patients: 17
Inclusion Criteria: Age 50 or older; advanced dry AMD with GA in the study eye; BCVA Snellen equivalent of 20/80 or worse in the study eye using ETDRS charts at a starting distance of 4 m after the first 3 patients are enrolled and demonstrate favorable safety data; total GA lesion size 5 mm2 (2 DA) to 20 mm2 (8 DA) in the study eye; if multifocal, then at least one focus of GA needs to measure 1.27 mm2 (0.5 DA); fellow eye BCVA of 20/800 or better and must be the eye with the better visual acuity; must be willing to undergo paracentesis of the anterior chamber
Exclusion Criteria: GA secondary to non-AMD etiologies; prior or active choroidal neovascularization (CNV) in the study eye; history of conditions in the study eye during screening which might alter visual acuity or interfere with study testing; active uncontrolled glaucoma; intraocular surgery in the study eye within 3 months of enrollment or are known or likely candidate for intraocular surgery (including cataract surgery) in the study eye within 1 year of treatment; acute or chronic infection in the study eye; history of inflammation in the study eye or ongoing inflammation in either eye; history of uveitis in the study eye; ongoing ocular inflammation in either eye; any contraindication to intravitreal injection; currently using or have used treatment for exudative AMD in the study eye only: laser photocoagulation, photodynamic therapy (PDT), ranibizumab (Lucentis), pegaptanib sodium (Macugen), bevacizumab (Avastin) or aflibercept (Eylea); currently using any periocular (study eye), intravitreal (study eye) or systemic (oral or intravenous) corticosteroids within 3 months prior to screening; any significant poorly controlled illness that would preclude study compliance and follow-up; current or prior use of any medication known to be toxic to the retina or optic nerve including, but not limited, to chloroquine/hydrochloroquine, deferoxamine, phenothiazines and ethambutol; previous treatment with any ocular or systemic gene transfer product; received any investigational product within 120 days prior to screening.
Information: schong@eyeboston.com
Study: Study of Subretinal Implantation of Human Embryonic Stem Cell-Derived RPE Cells in Advanced Dry AMD
ClinicalTrials.gov Identifier: NCT02590692
Sponsor: Regenerative Patch Technologies, LLC
Purpose: The Phase I/IIa clinical trial is designed to assess the feasibility of delivery and safety of human embryonic stem cell-derived RPE cells on a parylene membrane (CPCB-RPE1) in patients with advanced, dry age-related macular degeneration.
Design: Single Group Assignment, Open
Number of Patients: 20
Inclusion Criteria: Patients able to understand and willing to sign the informed consent. Adult male or female patients with the age of 55 to 85 (inclusive) years who are not employees of the trial sites; in sufficiently good health to reasonably expect survival for at least 5 years after treatment; clinical findings consistent with advanced dry AMD with evidence of one or more areas of ≥1.25 square millimeter of geographic atrophy involving the central fovea; geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF; the best-corrected visual acuity (BCVA) of the eye to receive the implant will be equal or worse than 20/200 in the first half of the study patients and between 20/80 and 20/400 (inclusive) in the second half of the patients. The BCVA of the eye that is NOT to receive the implant will be better or equal to the eye that will receive the implant; medically suitable to undergo pars plana vitrectomy and the surgical implant procedure, including being able to position post-operatively and use post-operative medications as required; medically suitable for general anesthesia or monitored intravenous sedation, if needed; patients who are pseudophakic or aphakic in the study eye; if designated as an organ donor, willing to forego live organ donation; willing to consent to the post-mortem removal of the implant from the treated eye for the sponsor's analysis. The patient may also elect to donate the implanted and fellow, untreated eye, for histological analysis; able to understand the requirements of the study and willing and able to participate in long term follow up.
Exclusion Criteria: Presence of active or inactive choroidal neovascularization (CNV); presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serous choroidopathy or any other inflammatory ocular disease except dry eye syndrome; presence or history of severe, end-stage corneal dystrophy; history of steroid induced ocular hypertension or glaucoma; presence of moderate to severe glaucomatous optic neuropathy in the study eye, uncontrolled IOP, use of 2 or more topical agents to control intraocular pressure; history of glaucoma-filtering surgery; presence of moderate to severe nonproliferative diabetic retinopathy in the study eye; presence of any proliferative diabetic retinopathy in the study eye; presence of uncontrolled diabetes mellitus (HbA1c >8) at the time of screening; history of retinal detachment or retinal detachment repair in the study eye other than peripheral retinal tears or holes treated exclusively with laser or cryotherapy; presence of any other sight-threatening ocular disease; history of cognitive impairments or dementia which may impact the patient's ability to participate in the informed consent process and to appropriately complete evaluations; history of any immunodeficiency; evidence of herpetic or other viral eye disease; any current use of immunosuppressive therapy other than intermittent or low dose corticosteroids; participation within previous 3 months in any clinical trial of a drug by ocular or systemic administration (within previous 18 months for sustained release products); axial myopia of greater than -8 diopters in the eye that is to be implanted; axial length greater than 28 mm in the eye that is to be implanted; history of malignancy within the past 5 years (with the exception of successfully treated [excised] basal cell carcinoma [skin cancer] or successfully treated squamous cell carcinoma of the skin); history of myocardial infarction in previous 12 months; alanine transaminase/aspartate aminotransferase (ALT/AST) >3.0 times the upper limit of normal or any known liver disease; renal insufficiency, as defined by estimated creatinine clearance of <45 mL/min; a positive (or "reactive") test for HIV, or Hepatitis B, or Hepatitis C. A hemoglobin concentration of less than 10 gm/dl, a platelet count of less than 100K/µL or an absolute neutrophil count of less than 1000/µL at study entry; ocular lens removal within the previous 6 weeks in either eye; any other ocular surgery in the study eye in the previous 3 months; if female, pregnancy, the wish to become pregnant, or lactation; any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.
Information: GAquino@laretina.com
Study: An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02848313
Sponsor: Stealth BioTherapeutics
Purpose: To test 40 mg of elamipretide administered as a once daily 1.0 mL subcutaneous injection for 12 weeks.
Design: Safety, Single Group, No Masking, Treatment
Number of Patients: 40
Inclusion Criteria: No evidence of choroidal neovascularization (active or prior history) in the study eye; geographic atrophy may be multifocal, but the cumulative GA lesion size must be: ≥1.27 mm2 (approximately ≥0.5 DA) and ≤10.16 mm2 (approximately ≤4 DA); must reside completely within the FAF imaging field (field 2 to 30-degree image centered on the fovea); presence of measurable hyper autofluorescence adjacent to the discrete foci of GA. OR Intermediate AMD - high-risk drusen without GA disease group.
Exclusion Criteria: Age-related macular degeneration with any evidence of central GA (i.e., involving the fovea); atrophic retinal disease because of causes other than AMD; presence or diagnosis of exudative AMD or choroidal neovascularization in the study eye; history of diabetic retinopathy (a history of diabetes mellitus without retinopathy is not a criterion for exclusion); presence of vitreous hemorrhage; history of retinal detachment or macular hole (stage 3 or 4) in the study eye; presence of macular pucker.
Information: kit.oldham-creamer@stealthbt.com
Study: Zimura in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02686658
Sponsor: Ophthotech
Purpose: To evaluate the safety and efficacy of intravitreous administration of Zimura when administered in subjects with geographic atrophy (GA) secondary to dry age-related macular degeneration.
Design: Randomized, Parallel Assignment, Double-Blind, Treatment
Number of Patients: 200
Inclusion Criteria: Diagnosis of nonfoveal GA secondary to dry AMD; age 50 or older.
Exclusion Criteria: Retinal atrophy involving the fovea; evidence of CNV; any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals; any intraocular surgery or thermal laser within 3 months of trial entry; any prior thermal laser in the macular region, regardless of indication; any ocular or periocular infection in the 12 weeks prior to entry; previous therapeutic radiation in the region of the study eye; any sign of diabetic retinopathy in either eye.
Information: Lillian.vazquez@Ophthotech.com
Study: TOGA: Clinical Study to Evaluate Treatment With ORACEA for Geographic Atrophy
ClinicalTrials.gov Identifier: NCT01782989
Sponsor: Paul Yates, MD, PhD/MEDARVA
Purpose: To evaluate the efficacy and safety of ORACEA in the treatment of geographic atrophy due to dry age-related macular degeneration.
Design: Randomized, Parallel Assignment, Double-Blind, Treatment
Number of Patients: 286
Inclusion Criteria: Best-corrected visual acuity of 20/20 - 20/400 in the study eye; best-corrected visual acuity of hand motion or better in the nonstudy eye; clinical diagnosis of geographic atrophy secondary to nonexudative age-related macular degeneration in at least 1 eye (study eye); geographic atrophy lesions of ≥0.5 and ≤7.0 MPS disc areas.
Exclusion Criteria: History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the study eye; history of or active presence of choroidal neovascularization secondary to exudative AMD in the nonstudy eye requiring any treatment within 12 months prior to Day 0.
Information: pay2x@virginia.edu, aml7q@virginia.edu
Study: Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With AMD
ClinicalTrials.gov Identifier: NCT02564978
Sponsor: National Eye Institute
Purpose: To see if minocycline is safe for people with GA and if it helps preserve their vision.
Design: Single Group Assignment, No Masking, Treatment
Number of Patients: 60
Inclusion Criteria: Participant must be 55 years or older; must have evidence of early or intermediate AMD as defined by characteristic presence of drusen and/or pigmentary changes; participant must be able to swallow capsules.
Exclusion Criteria: Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve (e.g., ethambutol, chloroquine, or hydroxychloroquine); participant has a condition that would preclude participation in the study.
Information: Angela.kibiy@nih.gov
Study: Alpha Lipoic Acid in Geographic Atrophy
ClinicalTrials.gov Identifier: NCT02613572
Sponsor: University of Pennsylvania
Purpose: To determine if there are safety/tolerability concerns seen when higher doses of alpha lipoic acid are taken by subjects 65 years of age or older.
Design: Safety, Randomized, Single Group, Open Label 15, Treatment
Number of Patients: 65
Inclusion Criteria: Between 65 and 90 years old; female participants must be menopausal, male participants are required to use contraception; able to give informed consent; for the study duration (15 days), the subject must remain in the country, remain within 4 hours of travel time (by car or airplane), have access to medical care if needed, and provide contact information so the subject can be reached as needed.
Exclusion Criteria: Blood pressure greater than 190/100 at the baseline visit; pulse greater than 100 at the baseline visit; acute and ongoing systemic infection; history of dementia; participant has a condition that, in the opinion of the investigator, gives them an unstable medical status; participant has geographic atrophy and the investigator believes the participant is a candidate for enrollment into the planned Phase 2 trial for geographic atrophy.
Information: benjamin.kim@uphs.upenn.edu
Study: PRO-CON: IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD
ClinicalTrials.gov Identifier: NCT02462889
Sponsor: Jeffrey S. Heier, MD/Regeneron
Purpose: To evaluate intravitreal aflibercept injection (IAI) vs sham as prophylaxis against conversion to neovascular age-related macular degeneration (AMD) in “high-risk” subjects.
Design: Randomized, Parallel Assignment, Single-Blind, Prevention
Number of Patients: 128
Inclusion Criteria: Study eye must have a diagnosis of nonexudative age-related degeneration characterized by the presence of many intermediate sized drusen, 1 or more large drusen, and/or hyperpigmentary changes. Fellow (nonstudy) eye must have CNV lesion (i.e., leakage on fluorescein angiography and/or subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration OR history of CNV lesion secondary to age-related macular degeneration, as confirmed by current or past treatment or current or past diagnostic imaging.
Exclusion Criteria: Evidence of neovascular AMD in the study eye at time of enrollment or anytime in the past. The reading center must confirm that there is no evidence of neovascular AMD in the study eye prior to enrollment; serous PED of any size in the study eye, as determined by the reading center; previous treatment with verteporfin PDT, anti-VEGF therapy, laser, external beam radiation or other AMD therapy in the study eye.
Information: anowak@eyeboston.com
Study: PRELUDE: A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy
ClinicalTrials.gov Identifier: NCT02659098
Sponsor: Janssen Research & Development, LLC
Purpose: To evaluate the safety and performance profile of a modified surgical procedure and custom delivery devices and also to assess the effects on visual acuity of a single subretinal administration of CNTO 2476.
Design: Randomized, Parallel Assignment, Double-Blind, Treatment
Number of Patients: 21
Inclusion Criteria: Confirmed diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 45 days prior to initial randomization by the central reading center; study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 [Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR) value 0.6-1.6]. BCVA in the treatment eye must be worse than the BCVA in the fellow eye at screening.
Exclusion Criteria: Participant has a history of neovascular (“wet”) AMD in the treatment eye, including any evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization. History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to Screening; geographic atrophy secondary to any causes other than AMD in either eye.
Information: https://jnj.prod.sylogent.com/scr/Home.aspx?CR106814
Study: METforMIN: Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD
ClinicalTrials.gov Identifier: NCT02684578
Sponsor: University of California, San Francisco
Purpose: To determine whether metformin, an FDA-approved drug for the treatment of type II diabetes, is a safe and effective treatment to decrease the progression of geographic atrophy in nondiabetic patients with age-related macular degeneration.
Design: Randomized, Safety/Efficacy, Parallel Assignment, Single-Blind, Treatment
Number of Patients: 186
Inclusion Criteria: Subject must have evidence of advanced dry AMD, defined by the characteristic presence of drusen and/or pigmentary changes, as well as geographic atrophy; subject must have clear ocular media and adequate pupillary dilation; study eye must have best corrected visual acuity (BCVA) of 20/20-20/400.
Exclusion Criteria: Subjects with insufficient baseline size of geographic atrophy, less than 1.25 mm2 (0.5 Macular Photocoagulation Study Disc Areas). GA is defined as one or more well-defined and often circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may be classified as early GA. The GA in the study eye must be able to be photographed in its entirety, and it must not be contiguous with any areas of peripapillary atrophy, which can complicate area measurements.
Information: eyestudy@ucsf.edu
WET AMD
NEW Study: ARCHWAY: A Phase III Study to Evaluate the Port Delivery System Implant With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT03677934
Sponsor: Hoffman-La Roche
Purpose: Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).
Design: Randomized, parallel assignment, single masking
Number of Patients: 360
Inclusion Criteria: Age ≥50 years, at time of signing Informed Consent Form. Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit. Previous treatment with at least three anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit. Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis. Best-corrected visual acuity (BCVA) of 34 letters or better.
Exclusion Criteria: Subfoveal fibrosis or subfoveal atrophy in study eye. Subretinal hemorrhage that involves the center of the fovea in study eye. History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye. Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in study eye. Previous intraocular device implantation in study eye. Previous laser (any type) used for AMD treatment in study eye. Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye. Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye. CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye. Uncontrolled blood pressure. History of stroke within the last 3 months prior to informed consent. Uncontrolled atrial fibrillation within 3 months of informed consent. History of myocardial infarction within the last 3 months prior to informed consent. History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications in the opinion of the investigator. Current systemic treatment for a confirmed active systemic infection. Chronic use of oral corticosteroids. Active cancer within 12 months of randomization. Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals).
NEW Study: AAVCAGsCD59 for the Treatment of Wet AMD
ClinicalTrials.gov Identifier: NCT03585556
Sponsor: Hemera Biosciences
Purpose: Patients with treatment naive wet AMD will receive an intravitreal anti-VEGF injection at Day 0 followed by an intravitreal injection of AAVCAGsCD59 at Day 7. Patients will be followed monthly through Month 12 and receive an intravitreal anti-VEGF injection as needed based on an increase in central subfoveal thickness (CST) of >50 micrometers on OCT from Day 0, new subretinal hemorrhage on clinical exam, and/or loss of 10 or more ETDRS letters from the previous month exam.
Design: Single group, no masking
Number of Patients: 10
Inclusion Criteria: Men or women 50 years of age or older. Treatment naive Wet AMD with no evidence of subretinal fibrosis under the fovea. Presence of intraretinal and/or subretinal fluid on OCT. Best corrected visual acuity (BCVA) Snellen equivalent 20/25 to 20/400 in the study eye using ETDRS charts at a starting distance of 4m. Adequate pupillary dilation to permit ocular examination and testing. Ability and willingness to return for all scheduled visits and assessments. Understand and comply with the clinical protocol and provide written informed consent prior to any study-related procedure. All fertile men must be willing to use barrier contraception during the study. Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception for the duration of the trial. A woman of childbearing potential is defined as any female who has had menses within the last two years or has not undergone a hysterectomy or surgical sterilization.
Exclusion Criteria: Wet AMD secondary to non-AMD etiologies. Subretinal hemorrhage that interferes with the ability to adequately measure visual acuity or follow retinal or subretinal fluid collection on OCT. Serous pigment epithelial detachment (PED) that is >50% of the CNV lesion, >400µm in any diameter, or presence of a RPE tear. Presence of polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous retinopathy, or symptomatic vitreomacular adhesion. Previous macular laser photocoagulation for CNV, photodynamic therapy (PDT), ocular radiation, or subretinal surgery for CNV in the study eye. History of conditions in the study eye which might alter visual acuity or interfere with study testing including clinically significant macular edema, central retinal vein occlusion, macular branch retinal vein occlusion, and optic neuropathy. Active uncontrolled glaucoma with IOP>30 mmHg despite treatment with glaucoma medications, cup-to-disc ratio of >0.9, visual field defects secondary to glaucoma that involve the macula, and optic atrophy from glaucoma. Likely candidate for intraocular surgery (including cataract surgery) in the study eye during the clinical trial. Acute or chronic infection in the study eye. History of uveitis unrelated to eye surgery in the study eye or opposite eye requiring treatment with topical corticosteroids or systemic immunosuppression within 24 months of enrollment. Any contraindication to intravitreal injection. Use intravitreal (study eye) corticosteroids within 3 months prior to screening. Any of the following underlying systemic diseases: Unstable or severe cardiovascular disease, e.g., congestive heart failure (New York Heart Association Functional class III or IV), myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina, or critical limb ischemia; Cerebrovascular disease within 12 months prior to Screening that impairs the patient's ability to participate in the clinical trial; Dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease) of a level that prevents adequate evaluation of the subject during the study; Has an active malignancy or is currently undergoing treatment for an active malignancy at Screening, or has a history of malignancy that precludes completion of this 12-month study; Immunocompromised conditions and/or need for immunosuppressive therapy. Any significant poorly controlled illness that would preclude study compliance and follow-up. Current or prior use of any medication known to be toxic to the retina or optic nerve including, but not limited, to chloroquine/hydrochloroquine, deferoxamine, phenothiazines and ethambutol. Previous treatment with any ocular or systemic gene transfer product. Received any investigational product within 120 days prior to screening. Any psychological, familial, sociological, geographical, or other condition that would preclude study compliance and follow-up.
Information: info@hemerabiosciences.com; schong@eyeboston.com
Study: Evaluating Abicipar for Safety and Treatment Effect in Patients With Neovascular Age-related Macular Degeneration (AMD)
ClinicalTrials.gov Identifier: NCT03539549
Sponsor: Allergan
Purpose: The objective of this study is to evaluate abicipar for safety and treatment effect in patients with neovascular Age-related Macular Degeneration (AMD).
Design: Single group, no masking
Number of Patients: 100
Inclusion Criteria: Diagnosis in the study eye of active, pathologic, newly diagnosed and previously untreated, subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD; Aged 50 years or older; Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye
Exclusion Criteria: Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye; Prior use within the last 3 months or a high possibility of requiring treatment with anti-VEGF therapy in the fellow eye during the study; Significant retinal serous pigment epithelial detachment (PED), atrophy, or fibrosis/scar involving the fovea; History of or current clinical evidence in the study eye of aphakia, diabetic macular edema, any ocular inflammation or infections, pathological myopia, retinal detachment, advanced glaucoma, and/or significant media opacity, including cataract; History or evidence of the following surgeries in the study eye: penetrating keratoplasty or vitrectomy; corneal transplant; corneal or intraocular surgery within 3 months of Screening; Uncontrolled hypertension despite use of antihypertensive medications; Participation in any investigational drug or device study, systemic or ocular, within past 3 months; Women who are pregnant or nursing; Women of child-bearing potential who are not using a highly effective form of birth control; Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation
Study: Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
ClinicalTrials.gov Identifier: NCT03479372
Sponsor: PanOptica, Inc.
Purpose: Double-masked, uncontrolled, multi-center, study in which participants will be randomized to one of 3 doses of topical ocular PAN 90806 administered once daily for 12 weeks.
Design: Randomized, parallel assignment
Number of Patients: 60
Inclusion Criteria: Male or female patients, 50 years of age or older at the time of informed consent; BCVA ≤78 and ≥24 letters (20/32 to 20/320 Snellen equivalents, respectively) at screening and at baseline (Day 1, prior to treatment) visits in the study eye; BCVA of 34 letters (Snellen equivalent 20/200) or better at baseline (Day 1, prior to treatment) in the non-study eye
Exclusion Criteria: Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye); Previous or concurrent macular laser treatment (study eye); Cataract or refractive surgery within 3 months prior to baseline ( study eye)
Information: IR‐CTRegistration@Allergan.com
Study: Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis Compared to Lucentis in Wet Age-related Macular Degeneration Subjects
ClinicalTrials.gov Identifier: NCT03211234
Sponsor: Santen Inc.
Purpose: To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis in subjects with wet age-related macular degeneration (AMD) compared with Lucentis alone.
Design: Randomized, parallel assignment, double masking
Number of Patients: 51
Inclusion Criteria: Provided signed written informed consent, diagnosis of active choroidal neovascularization secondary to wet AMD, BCVA of 65 to 25 ETDRS letters (20/50 to 20/320) in the study eye, BCVA of 25 ETDRS letters (20/320) or better in the fellow eye.
Exclusion Criteria: Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1 and throughout the study, Uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye, evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study, need for ocular surgery in the study eye during the course of the study, presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform examinations, allergy or hypersensitivity to study drug product, fluorescein dye or other study related procedures and medications, current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study, participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study, females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study, unable to comply with study procedures or follow-up visits.
Information: clinicaltrials@santen.com
Study: Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF
ClinicalTrials.gov Identifier: NCT03071055
Sponsor: Southeast Clinical Research Associates, LLC
Purpose: This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.
Design: Non-randomized, single group assignment, open label
Number of Patients: 20
Inclusion Criteria: Age >50 years, exudative age related macular degeneration in study eye involving the fovea, Best Corrected Visual Acuity (by ETDRS) letter score in study eye of <85 and >24 (approximate Snellen equivalent 20/20 to 20/320), persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye, at least 30 days from last intravitreal anti-VEGF injection in the study eye.
Exclusion Criteria: Patient who are receiving systemic anti-VEGF or proangiogenic therapy, patients on chronic high doses corticosteroid therapy (>than 10 mg of oral prednisone or equivalent greater than 10 days), patients on chronic immunosuppressant therapy, patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine, history of intravitreal corticosteroids in study eye within 4 months of baseline, uncontrolled hypertension (defined as systolic >180 mm Hg and/or diastolic >100 mm Hg while patient is sitting), history of stroke or APTC event in the previous year, any intraocular surgery in study eye within 90 days of baseline, presence of vitreomacular traction in study eye, presence of significant epiretinal proliferation in study eye, evidence of active infection in either eye, uncontrolled glaucoma in the study eye defined as a pressure >25 mmHg on maximal medical therapy.
Information: aprice@ceenta.com, ana@ceenta.com
Study: DECO: Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
ClinicalTrials.gov Identifier: NCT03452527
Sponsor: Iconic Therapeutics, Inc.
Purpose: The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.
Design: Randomized, parallel assignment, open label
Number of Patients: 20
Inclusion Criteria: Males or females of any race,
Exclusion Criteria: Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins, any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months, vitrectomy in the study eye.
Information: clinicaltrials@iconictherapeutics.com
Study: A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
ClinicalTrials.gov Identifier: NCT03150589
Sponsor: Samsung Bioepis Co., Ltd.
Purpose: This is a randomized, double-masked, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis in subjects with neovascular AMD.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 704
Inclusion Criteria: Age ≥50 years. Newly diagnosed, active subfoveal choroid neovascularization (CNV) lesion secondary to AMD in the study eye. BCVA of 20/40 to 20/200 in the study eye. Written informed consent form.
Exclusion Criteria: Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye. Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia. Any concurrent macular abnormality other than AMD in the study eye.
Information: sbregistry@samsung.com
Study: An 18-Month Phase Ib/II Multi-Center, Open Label Study to Evaluate the Safety of Intravitreal APL-2 Therapy in Patients With Neovascular Age-Related Macular Degeneration (AMD)
ClinicalTrials.gov Identifier: NCT03465709
Sponsor: Apellis Pharmaceuticals
Purpose: Safety assessment of APL-2 in patients with neovascular AMD.
Design: Single group, no masking
Number of Patients: 10
Inclusion Criteria: Age greater than or equal to 60 years. Normal Luminance best corrected visual acuity (NL-BCVA) of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (20/320 Snellen equivalent). Clinical diagnosis of neovascular AMD with the following criteria met: Eligible for an injection of an anti-VEGF injection with macular fluid present at Day -28; Must have been treated with anti-VEGF in study eye for at least 6 months prior to joining the study; At least 6 months of intravitreal anti-VEGF therapy at intervals not greater than 8 weeks (± 7 days) for the past 2 injections in the eye that is selected to be the study eye. A clinically meaningful (50%) reduction in excess macular fluid or macular thickness in the study eye at the discretion of the investigator between Screening Day -28 and Screening Day -14 as assessed by SD-OCT. Female subjects must be: Women of non-child-bearing potential (WONCBP), or Women of child-bearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study. Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study. Willing and able to give informed consent and to comply with the study procedures and assessments.
Exclusion Criteria: Presence of other causes of choroidal neovascularization (CNV) including pathologic myopia (spherical equivalent ≥-6 diopters), central serous chorioretinopathy, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis. History of vitrectomy to the study eye. Presence of any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator, interferes with ophthalmologic examination (e.g. advanced cataract or corneal abnormalities). Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization. Any history of endophthalmitis. Trabeculectomy or aqueous shunt or valve in the study eye. Aphakia or absence of the posterior capsule. Note: previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to baseline.
Any ophthalmic condition that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period (e.g. severe uncontrolled glaucoma, clinically significant diabetic macular edema, ischemic optic neuropathy, retinal vasculopathies). Any contraindication to IVT injection including current ocular or periocular infection. Current treatment for active systemic or localized infection. Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary. Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 24- month treatment period unlikely, or would make the subject an unsafe study candidate. Any baseline laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation. Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution.
Information: www.allerganclinicaltrials.com
Study: Safety and Efficacy of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02462486
Sponsor: Allergan
Purpose: This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration.
Design: Randomized, parallel assignment, triple masking
Number of Patients: 946
Inclusion Criteria: Diagnosis of age-related macular degeneration in at least 1 eye; best corrected visual acuity of 20/40 to 20/320 in the study eye; best corrected visual acuity of 20/200 or better in the non-study eye.
Exclusion Criteria: History of vitrectomy, macular surgery, or glaucoma surgery in the study eye; cataract or refractive surgery in the study eye within the last 3 months.
Information: www.allerganclinicaltrials.com
Study: ZEBRA: Ziv-aflibercept Efficacy in Better Regulating AMD
ClinicalTrials.gov Identifier: NCT03423823
Sponsor: Kapil Kapoor
Purpose: This is a randomized, open-label, interventional, controlled study to determine the effects of Zaltrap on Neovascularized Wet Macular Degeneration as compared to the control anti-vascular endothelial growth factor ("anti-VEGF") injections (bevacizumab, ranibizumab, or aflibercept).
Design: Randomized, parallel assignment, no masking
Number of Patients: 100
Inclusion Criteria: Are age 50-99; have neovascular Age-related Macular Degeneration ("AMD") with an eye undergoing maintenance treatment with one or more of the following anti-VEGF drugs: bevacizumab, ranibizumab, or aflibercept; have an eye undergoing treatment that is of low visual potential (20/200 Snellen equivalent or worse) and the contralateral eye must have better visual potential; are willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments; have received an intravitreal injection of one of the drugs listed above within 120 days of Day 1 of the trial. Both males and females will be enrolled.
Exclusion Criteria: Active intraocular inflammation or infection; history of vitreous hemorrhage within three months prior to Day 1 of the study; Uncontrolled ocular hypertension or glaucoma in the study eye (defined as Intraocular Pressure ("IOP") >25 mm Hg or a Cup to Disc ratio >0.8 despite treatment with anti-glaucoma medication) or any such condition which the investigator feels may warrant a glaucoma filtering surgery during the study; History of stroke within the last three months prior to Day 1 of the study; History of myocardial infarction within the last three months prior to Day 1 of the study; Undergone intraocular surgery or laser treatments within the last three months; Significant Epiretinal Membrane ("ERM") or Vitreomacular Traction ("VMT") causing distortion of macular anatomy; No use of ocular corticosteroids within the last six months and no use of systemic corticosteroids at a dose of >10 mg/day; Not have active malignancies within the last 12 months except appropriately treated carcinoma in situ of the cervix, melanoma, and prostate cancers treated with a curative intent; Inability to comply with study or follow-up procedures; Women who may become pregnant or lactating or intend to become pregnant during the study; Women who are of childbearing potential, including women who have had tubal ligation, must have a blood test within 21 days prior to Day 1 of the study. A woman is considered to not be of childbearing potential if she is postmenopausal or has undergone hysterectomy and/or bilateral oophorectomy. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
Information: research@wagnerretina.com
Study: Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results
ClinicalTrials.gov Identifier: NCT01657669
Sponsor: Retina Research Institute, LLC
Purpose: This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD).
Design: Single Group Assignment, No Masking, Treatment
Number of Patients: 22
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Age 50 years and above. Choroidal neovascularization secondary to AMD with central retinal thickness greater than or equal to 300 um. Best corrected visual acuity in the study eye between 20/40 and 20/400 using an ETDRS chart.
Exclusion Criteria: Pregnancy (positive urine pregnancy test) or lactation. Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. Participation in a study or an investigational drug or device within the past 30 days prior to enrolling in the study. Presence of significant subfoveal fibrosis or atrophy. Previously treated subjects: Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline More than six (6) prior treatments with anti-VEGF therapy in the study eye within 1 year. Prior treatment with PDT within the past 3 months or more than 2 prior PDT treatments.
Prior treatment with intravitreal aflibercept injection Prior treatment with triamcinolone in the study eye within 6 months of baseline. Prior treatment with dexamethasone in the study eye within 30 days prior to baseline. Intraocular surgery (including cataract surgery)in the study eye within 2 months preceding baseline. History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye. Active intraocular inflammation (grade trace or above) in the study eye. Current vitreous hemorrhage in the study eye. History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye. Uncontrolled glaucoma in the study eye (defined as IOP greater than or equal to 30 mmHg despite treatment with anti-glaucoma medication). History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment. History of allergy to fluorescein, ICG or iodine, not amenable to treatment. History of retinal pigment epithelial tear or rip.
Study: NVAMD: ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT03362190
Sponsor: Ophthotech Corporation
Purpose: To assess the safety of intravitreal Zimura (complement factor C5 inhibitor) administered in combination with Lucentis 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD).
Design: Randomized, Parallel Assignment, No Masking, Treatment
Number of Patients: 60
Inclusion Criteria: Active subfoveal NVAMD
Exclusion Criteria: History or evidence of severe cardiac disease; any major surgical procedure within one month of trial entry; subjects with a clinically significant laboratory value; any treatment with an investigational agent in the past 60 days for any condition; women who are pregnant or nursing; known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation; any prior treatment for AMD other than oral supplements of vitamins and minerals.
Information: denise.teuber@ophthotech.com
Study: A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
ClinicalTrials.gov Identifier: NCT03249740
Sponsor: Graybug Vision
Purpose: The purpose of this study is to evaluate the safety and efficacy of single and repeated intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular degeneration.
Design: Randomized, Parallel Assignment, Triple Masking, Treatment
Number of Patients: 782
Inclusion Criteria: Males or females of any race, ≥50 years of age; presence of an active CNV lesion secondary to AMD treated with at least 3 monthly injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab); evidence of increased vascular permeability and/or loss of visual acuity.
Exclusion Criteria: History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke; uncontrolled hypertension, diabetes mellitus, IOP, hypothyroidism, or hyperthyroidism; chronic renal disease; abnormal liver function; women who are pregnant or lactating.
Information: vsmith@graybug.com
Study: A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
ClinicalTrials.gov Identifier: NCT03345082
Sponsor: Opthea Limited
Purpose: A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.
Design: Randomized, Parallel Assignment, Quadruple Masking, Treatment
Number of Patients: 351
Inclusion Criteria: Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD; an ETDRS BCVA score between 60 and 25 (inclusive) letters.
Exclusion Criteria: Previous treatment for wet AMD or previous treatment for CNV due to other causes in the Study Eye; clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye; poorly controlled diabetes mellitus (defined as HbA1c>7%); any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study.
Information: OPT1002_ClinicalTrialsGov@ppdi.com
Study: NEAMES: Episcleral Brachytherapy for the Treatment of Wet AMD
ClinicalTrials.gov Identifier: NCT02988895
Sponsor: Salutaris Medical Devices, Inc.
Purpose: This is a prospective, single-arm, open-label, safety, usability and tolerability trial of Strontium 90 (Sr90) beta radiation episcleral brachytherapy in subjects receiving aflibercept therapy pro re nata (PRN) for the treatment of early neovascular age-related macular degeneration (nAMD) lesions. Secondary aims are to observe clinical outcomes of area of leakage, subretinal fluid, lesion size, visual acuity, and anti-vascular endothelial growth factor (anti-VEGF) treatment burden.
Design: Single Group, No Masking, Treatment
Number of Patients: 20
Inclusion Criteria: Diagnosis of CNV due to nAMD; Male or female aged 50 years or older; Documented continued care for nAMD since diagnosis; Patients must have demonstrated clinical or OCT/angiographic evidence that, in the investigator's opinion, requires treatment with anti-VEGF therapy; BCVA 20/40 - 20/200 Snellen equivalent in study eye; Actively leaking CNV as determined by FA.
Exclusion Criteria: Females of child-bearing potential (defined as <2 years post-menopausal)
CNV other than due to nAMD; Sub-foveal lesion hemorrhage obscuring >50% of lesion; CNV lesion with greatest linear dimension >2mm as determined by Intravenous Fluorescein angiography; Presence of subretinal fibrosis in the study eye; Existing Retinal Pigment Epithelial tear; Previous treatment (excluding vitamins) for nAMD in the study eye other than aflibercept anti-VEGF therapy in the last 6 months; A change in anti-VEGF agent in the previous 2 administrations; Anticipate a change to the anti-VEGF agent during the conduct of the study; Previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction; Other clinically significant ocular co-morbidity including, but not limited to, optic glaucoma, optic neuropathy of any cause, maculopathy/retinopathy of any cause other than nAMD, and scleritis; Refractive error of - 6D or greater (spherical equivalent) or demonstrated myopic degeneration; Media opacity sufficient to preclude adequate fundoscopy, OCT or angiography; Uncontrolled systemic diseases (eg, controlled hypertension is acceptable); Type I or type II diabetes mellitus; Clinically significant previous radiation to the eye; Unable to discontinue anticoagulation or dual anti-platelet therapy for 7 days before and after the study intervention.; Patient unsuitable for IV or local anesthesia; Any contraindication to anti-VEGF, fluorescein, topical and local anesthetics, topical antiseptics, or topical antibiotics to be used during the study; Active ocular or periocular infection or intraocular inflammation; Only eligible eye is the best seeing eye; Any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct.
Information: mdrew@salutarismd.com
Study: Carbidopa-levodopa in Neovascular AMD
ClinicalTrials.gov Identifier: NCT03022318
Sponsor: Robert W. Snyder, MD, PhD, PC
Purpose: The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due to "wet" (neovascular) AMD.
Design: Nonrandomized, Parallel Assignment, No Masking, Treatment
Number of Patients: 52
Inclusion Criteria: A diagnosis of AMD with choroidal neovascularization (CNV) in one eye; not previously treated with anti-VEGF injections; normal or dry AMD of any grade in the second eye; age 50 to 85; willingness to maintain AREDS vitamin supplements throughout the study, or remain off these supplements for the duration of the study, if not taking them prior to the study; signed informed consent.
Exclusion Criteria: Any current use of L-DOPA containing medication or dopamine agonist medication, or any planned use of any of these agents, except for study medication, during the study; concurrent use of monoamine oxidase (MAO) inhibitors; any eye condition, disease, or history of trauma in either eye, which can impair vision, except cataract or cataract surgery; BCVA worse than 20/160 in the better eye; wet AMD in the second eye; neurologic conditions which can impair vision; Parkinson’s Disease; significant orthostatic hypotension, defined as a drop in systolic blood pressure, immediately upon changing from the supine to standing position, of >19 mmHg, or a symptomatic drop in systolic blood pressure, immediately upon changing from the supine to standing position; significant ECG abnormalities, as judged by the investigator; estimated glomerular filtration rate (eGFR) <20 ml/min; Liver enzymes >3 X the upper limit of normal; HbA1c >9.0; any other significant lab abnormalities, as judged by the investigator; women of childbearing potential; known retinal hemorrhage; subjects who are not fluent in English.
Information: tcfaganmd@gmail.com; rsnyder781@gmail.com
Study: Dose Ranging Study of Carbidopa-levodopa
ClinicalTrials.gov Identifier: NCT03023059
Sponsor: Robert W. Snyder, MD, PhD, PC
Purpose: The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD who are already on treatment with anti-VEGF intraocular injections, and measure the effects on visual acuity, retinal abnormalities due to "wet" AMD, and document the number of anti-VEGF injections required during the study.
Design: Single Group, No Masking, Treatment
Number of patients: 52
Inclusion Criteria: A diagnosis of AMD with choroidal neovascularization (CNV) in one eye; not previously treated with anti-VEGF injections, OR on anti-VEGF injections for at least 3 months, and meets criteria for a repeat injection, OR patients, who have completed Study 001, may enter this trial at the point of initiation of the month of treatment with the dose of carbidopa-levodopa, that they received in Study 001; normal or dry AMD of any grade in the second eye; willingness to maintain AREDS vitamin supplements throughout the study, or remain off these supplements for the duration of the study, if not taking them prior to the study; informed consent at baseline.
Exclusion Criteria: Any current use of L-DOPA containing medication or dopamine agonist medication, or any planned use of any of these agents, except for study medication, during the study; concurrent use of monoamine oxidase (MAO) inhibitors; any eye conditions, disease, or history of trauma in either eye, which can impair vision, except cataract or cataract surgery; BCVA worse than 20/60 in the better eye; wet AMD in the second eye; neurologic conditions which can impair vision; Parkinson’s Disease; significant orthostatic hypotension, defined as a drop in systolic blood pressure, immediately upon changing from the supine to standing position, of >19 mmHg, or a symptomatic drop in systolic blood pressure, immediately upon changing from the supine to standing position; significant ECG abnormalities, as judged by the investigator; estimated glomerular filtration rate (eGFR) ,20 ml/min; liver enzymes >3 X the upper limit of normal; HbA1C>9.0; any other significant lab abnormalities, as judged by the investigator; women of childbearing potential; known retinal hemorrhage; subjects who are not fluent in English.
Information: tcfaganmd@gmail.com, rsnyder781@gmail.com
Study: IAI-OCTA: A study of OCT-Angiography Analysis Efficacy
ClinicalTrials.gov Identifier: NCT03022292
Sponsor: University of California, Los Angeles
Purpose: This study is utilizing a new, FDA approved, nonstandard of care technology (OCT-Angiography by Optovue) to image and evaluate the treatment outcomes of using standard of care Intravitreal Aflibercept Injections for their approved use in patients diagnosed with neovascular AMD who are naive to previous Anti-VEGF therapies.
Design: Single Group Assignment, No Masking
Number of Patients: 30
Inclusion Criteria: Older than 50; willing to participate in the study and able to follow study criteria and protocol; the study eye is treatment naïve regarding treatment of neovascular AMD; subject is willing and able to comply with clinic visits and study-related procedures; subject is able to provide signed informed consent; subject is able to understand and complete study-related questionnaires; subject is not currently involved with any other clinical study; BCVA with ETDRS Snellen equivalent of 20/400 or better and 20/32 or worse; sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA and fundus photography; IOP of 25 mmHg or less in the study eye, with or without use of ocular hypotensive agents; prior focal corticosteroid treatment is allowed, as long as the study eye is not involved. However prior (within 90 days of Day 0) or current systemic corticosteroid therapy (oral or intravenous corticosteroid treatment) is not permitted.
Exclusion Criteria: Any prior treatment of neovascular AMD in the eye proposed for enrollment including previous anti-vascular endothelial factor (anti-VEGF) therapy, photodynamic therapy (PDT), radiation therapy, corticosteroid treatment, surgical treatment for CNV, thermal laser treatment, and any other prior intravitreal treatment for neovascular AMD (except minerals and vitamins); known serious allergies to aflibercept, fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation, topical anesthetic, or sterilizing solution (eg, Betadine Solution); prior or current systemic anti-VEGF therapy; pregnant or breast-feeding women; sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly); contraindication to pupillary dilation in study eye; any condition (including inability to read visual acuity charts, or language barrier) that may preclude subjects ability to comply with the study protocol and requirements; presence of any advanced systemic condition or end-stage disease, such as advanced Alzheimer Syndrome, end-stage cancer, etc., which will likely prevent subject from completing study; previous therapeutic radiation in the region of the study eye; prior retinal pigment epithelial (RPE) tear in study eye; prior ocular surgery (except YAG laser capsulotomy) for study within the past 90 days; anticipated ocular surgery 9except YAG laser capsulotomy) for the next 12 months; prior vitrectomy in the study eye; presence of any causes of CNV and PED other than due to AMD or presence of ocular disease other than AMD affecting study eye, ie presumed ocular histoplasmosis syndrome, android streaks, pathologic myopia.
Contact: harmon@jsei.ucla.edu, downey@jsei.ucla.edu
Study: CDER: A Safety and Efficacy Study of Abicipar Pegol in Patients With Neovascular Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02462928
Sponsor: Allergan
Purpose: To study abicipar pegol in patients with neovascular AMD.
Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-Blind, Treatment
Number of Patients: 939
Inclusion Criteria: Age 50 or older; untreated or previously treated choroidal neovascularization (CNV) lesion due to AMD; BCVA of approximately 20/200 Snellen or better in the nonstudy eye; diagnosis of AMD in at least 1 eye; BCVA of 20/40 to 20/320 in the study eye and 20/200 or better in the other.
Exclusion Criteria: History of vitrectomy, macular surgery, or glaucoma surgery in the study eye; cataract or refractive surgery in the study eye within the last 3 months.
Information: clinicaltrials@allergan.com
Study: RGX-314 Gene Therapy for Neovascular AMD Trial
ClinicalTrials.gov Identifier: NCT03066258
Sponsor: Regenxbio Inc.
Purpose: To test RGX-314’s ability to treat neovascular AMD.
Design: Non-randomized, Sequential Assignment, No Masking, Treatment
Number of Patients: 18
Inclusion Criteria: Patients ≥50 years with a diagnosis of subfoveal CNV secondary to AMD in the study eye receiving prior intravitreal anti-VEGF therapy; BCVA between ≤20/100 and ≥20/400 (≤53 and ≥19 Early Treatment Diabetic Retinopathy Study [ETDRS] letters) for the first patient in each cohort followed by BCVA between ≤20/63 and ≥20/400 (≤75 and ≥35 ETDRS letters) for the rest of the cohort; history of need for and response to anti-VEGF therapy; response to anti-VEGF at trial entry (assessed by SD-OCT at week 1); must be pseudophakic (status post cataract surgery) in the study eye; AST/ALT <2.5 × ULN; TB <1.5 × ULN; PT <1.5 × ULN; Hb >10 g/dL (males) and >9 g/dL (females); Platelets >100 × 10^3/µL; eGFR >30 mL/min/1.73 m^2; must be willing and able to provide written, signed informed consent.
Exclusion Criteria: CNV or macular edema in the study eye secondary to any causes other than AMD; any condition preventing visual acuity improvement in the study eye, eg, fibrosis, atrophy, or retinal epithelial tear in the center of the fovea; active or history of retinal detachment in the study eye; advanced glaucoma in the study eye; history of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to screening; presence of an implant in the study eye at screening (excluding intraocular lens); myocardial infarction, cerebrovascular accident, or transient ischemic attacks within the past 6 months; uncontrolled hypertension (systolic blood pressure [BP] >180 mmHg, diastolic BP >100 mmHg) despite maximal medical treatment.
Information: patientadvocacy@regenxbio.com
Study: MAKO: Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD
ClinicalTrials.gov Identifier: NCT02727881
Sponsor: Ohr Pharmaceutical
Purpose: A Phase 3 Study of the efficacy and safety of squalamine lactate ophthalmic solution 0.2% twice daily in subjects with neovascular AMD. Patients will receive injections of ranibizumab, and either Squalamine eye drops or placebo eye drops.
Design: Randomized, Parallel Assignment, Double-Blind, Treatment
Number of Patients: 230
Inclusion Criteria: Age 50 or older; a diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA); central subfield thickness (spectral domain (SD)-OCT central 1 mm) of
Exclusion Criteria: Neovascularization secondary to any other condition than AMD in the study eye (blood occupying greater than 50% of the AMD lesion, or blood >1.0 sq.mm underlying the fovea); pigment epithelial detachment (PED) without associated subretinal fluid and/or cystic retinal changes; clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye; confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease); fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement; uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye.
Contact: aingerman@ohrpharmaceutical.com, sshearn@ohrpharmaceutical.com
Study: Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD
ClinicalTrials.gov Identifier: NCT02599064
Sponsor: RXi Pharmaceuticals
Purpose: To evaluate the safety, tolerability and clinical activity of RXI-109 administered by intravitreal injection to reduce the progression of subretinal fibrosis in subjects with advanced neovascular age-related macular degeneration.
Design: Safety/Efficacy, Open Label, Single Group, Treatment
Number of Patients: 9
Inclusion Criteria: Subjects presenting with advanced NVAMD in the study eye with BCVA ≤20/200 potentially due to subretinal fibrosis involving the fovea; BCVA ≥20/800 in the contralateral eye and better than the study eye; ≥50 years of age; subfoveal CNV of any type.
Exclusion Criteria: Presence of other causes of CNV including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
Information: clinicaloperations@rxipharma.com
Study: Continuation of Previous Study to Gather More Data on Effect of Macugen on the Corneal Endothelium
ClinicalTrials.gov Identifier: NCT01573572
Sponsor: Valeant Pharmaceuticals International
Purpose: Due to the lack of information generated in the pivotal phase III trials assessing potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium, the FDA requested clinical information from a 1-year (minimum) clinical study to support that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Design: Single Group, Open Label
Number of Patients: 125
Inclusion Criteria: Subjects aged 50 years or older and diagnosed with subfoveal neovascular AMD, DME, or Retinal Vein Occlusion; best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/20 and 20/400 using a Snellen chart; women must be using 2 forms of effective contraception, be post-menopausal for at least 12 months prior to study entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The 2 forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication; provide written informed consent; ability to return for all study visits.
Exclusion Criteria: Unilateral ocular blunt trauma within 1 year of enrollment and no greater than 5% difference in central endothelial cell density between the 2 eyes; intraocular surgery (cataract surgery and surgery for glaucoma without tube shunt or mini-shunt) within 1 year of enrollment; anterior segment laser surgery (laser trabeculoplasty) performed within 1 year of enrollment; glaucoma tube-shunt surgery; previous history of corneal transplant in the study or nonstudy eye; presence of vitreous macular traction; previous therapeutic radiation in the region of the study eye; any treatment with an investigational agent in the past 30 days for any condition; known serious allergies to the components of pegaptanib sodium formulation. Any of the following underlying diseases, including: History or evidence of severe cardiac disease(eg, NYHA Functional Class III or IV - see Appendix 2), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrhythmias requiring ongoing treatment; history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation; history or evidence of clinically significant impaired renal or hepatic function; stroke (within 12 months of study entry); any major surgical procedure within one month of study entry; significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity; subjects should not be entered if there is likelihood that they will require cataract or glaucoma surgery in either eye during the study treatment and follow-up period.
Information: denise.raimondo@valeant.com
Study: DAWN: Dorzolamide-timolol in Combination With Anti-vascular Endothelial Growth Factor Injections for Wet Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT03034772
Sponsor: Wills Eye
Purpose: A previous pilot study demonstrated that commonly available glaucoma drops (dorzolamide-timolol) might decrease the amount of chronic swelling in patient with wet age-related macular degeneration who have been receiving anti-vascular endothelial growth factor (VEGF) injections. This will be a larger study where subjects are randomly assigned to receive the glaucoma drops or a placebo (artificial tears) to confirm whether this previous finding is valid.
Design: Randomized, Parallel Assignment, Single-Blind
Number of Patients: 50
Inclusion Criteria: Active choroidal neovascularization (CNV) due to AMD; prior treatment with at least 4 injections of anti-VEGF agents in the past 6 months and persistent intraretinal and/or subretinal fluid on SD-OCT at each visit during this period; baseline CST ≥270 µm on SD-OCT automated retinal thickness map; injection of the same anti-VEGF agent at each of the 2 visits immediately preceding study enrollment; time interval of 5 weeks (±1 week) between visits for at least 2 visits immediately preceding study enrollment; either gender aged ≥45 years.
Exclusion Criteria: History of uveitis; presence of intraocular inflammation, significant epiretinal membrane, significant vitreomacular traction, macular hole, or vitreous hemorrhage; any ophthalmic surgery within previous 6 months, including cataract extraction; any history of vitrectomy or glaucoma surgery; current prescription eye drop usage; any contraindication for topical use of a beta-blocker; any history of sulfonamide allergy.
Information: mformoso@midatlanticretina.com, kdiienno@midatlanticretina.com
Study: PREVENT: Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02140151
Sponsor: Southern California Desert Retinal Consultants
Purpose: To determine whether quarterly injections of ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration.
Design: Randomized, Efficacy, Parallel Assignment, Single-Blind, Prevention
Number of Patients: 100
Inclusion Criteria: Nonexudative age-related macular degeneration (AMD) in 1 eye (study eye); history of exudative AMD in 1 eye only (fellow eye) diagnosed within 5 years of study enrollment.
Exclusion Criteria: Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥-8 diopters or axial length of ≥25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), etc.
Information: mlalezary@desertretina.com
Study: LADDER: Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02510794
Sponsor: Genentech
Purpose: To evaluate the efficacy and the safety of 3 different formulations of ranibizumab, delivered via the Ranibizumab Port Delivery System (RPDS) implant, in patients with subfoveal neovascular age-related macular degeneration.
Design: Randomized, Safety/Efficacy, Parallel Assignment, Quadruple Masking, Treatment
Number of Patients: 220
Inclusion Criteria: Newly diagnosed with wet AMD within 9 months of screening visit; patient must have received at least 2 prior ITV anti-VEGF injections, with the most recent being ranibizumab and at least 7 days prior to screening; demonstrated response to prior standard of care; BCVA using ETDRS charts of 20/20 – 20/200 Snellen equivalent.
Exclusion Criteria: Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye; study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit; history of laser photocoagulation, Visudyne, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD.
Information: (888) 662-6728, global.rochegenetechtrials@roche.com
DIABETIC MACULAR EDEMA
NEW Study: A Study to Evaluate the Efficacy and Safety of RO6867461 in Participants With Diabetic Macular Edema (YOSEMITE)
ClinicalTrials.gov Identifier: NCT03622580
Sponsor: Hoffmann-La Roche
Purpose: This study will evaluate the efficacy, safety, and pharmacokinetics of RO6867461 administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
Design: Parallel assignment, randomized, triple masking
Number of Patients: 900
Inclusion Criteria: Type 1 or type 2 diabetes mellitus and hemoglobin A1c (HbA1c) of less than or equal to 10%. Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea. Decreased visual acuity attributable primarily to DME. Ability and willingness to undertake all scheduled visits and assessments. For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment.
Exclusion Criteria: Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1. Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest. Currently pregnant or breastfeeding, or intend to become pregnant during the study. Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye. Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye. Prior administration of IVT RO6867461 in either eye. Active intraocular or periocular infection or active intraocular inflammation in the study eye. Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye. Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye. Other protocol-specified inclusion/exclusion criteria may apply.
Study: Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KESTREL)
ClinicalTrials.gov Identifier: NCT03481634
Sponsor: Novartis Pharmaceuticals
Purpose: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Design: Parallel assignment, double masking
Number of Patients: 534
Inclusion Criteria: Written informed consent before any assessment; Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening; Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study
Exclusion Criteria: Active proliferative diabetic retinopathy in the study eye; Active intraocular or periocular infection or active intraocular inflammation in study eye; Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 millimeters mercury (mmHg); Previous treatment with anti-VEGF drugs or investigational drugs in the study eye; Stroke or myocardial infarction during the 6-month period prior to baseline; Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg; Other protocol-specified inclusion/exclusion criteria may apply.
Information: novartis.email@novartis.com
Study: A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)
ClinicalTrials.gov Identifier: NCT03511898
Sponsor: ThromboGenics
Purpose: This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.
Design: Nonrandomized, sequential assignment, no masking
Number of Patients: 12
Inclusion Criteria: Male or female aged 18 years or older; Type 1 or type 2 Diabetes Mellitus; Central-involved DME with central subfield thickness of ≥320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or ≥305µm on non-Spectralis SD-OCT, in the study eye; Best-corrected visual acuity (BCVA) ≤57 and ≥23 ETDRS letter score in the study eye; Non-proliferative diabetic retinopathy of any stage, or quiescent proliferative diabetic retinopathy, in the study eye; Written informed consent obtained from the subject prior to screening procedures
Exclusion Criteria: Macular edema due to causes other than DME; Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results; Any condition that could confound the ability to detect a change in central subfield thickness in the study eye; Previous confounding treatments/procedures, or their planned/expected use during the study period; Uncontrolled glaucoma in the study eye; Any active ocular / intra-ocular infection or inflammation in either eye; Poorly controlled Diabetes Mellitus; Uncontrolled hypertension
Information: info@thrombogenics.com
Study: Phase 4 IOP Signals Associated With ILUVIEN (PALADIN)
ClinicalTrials.gov Identifier: NCT02424019
Sponsor: Alimera Sciences
Purpose: The specific objectives include the study of intraocular pressure (IOP) related data in patients who received ILUVIEN and how it relates to the patient's experiences following prior treatment with a course of corticosteroid which did not result in a clinically significant IOP elevation.
Design: Single group, no masking
Number of Patients: 153
Inclusion Criteria: Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information.
Exclusion Criteria: Information: Study: ROBIN: A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.
ClinicalTrials.gov Identifier: NCT03238963
Sponsor: Boehringer Ingelheim
Purpose: The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47) or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without Center-involved diabetic macular edema (CI-DME).
Design: Randomized, parallel assignment, double blind
Number of Patients: 100
Inclusion Criteria: Of legal age (according to local legislation, usually ≥18 years) at screening, male or female patients (women of childbearing potential (WOCBP) must be ready and able to use two methods of contraception with at least one of them being a highly effective method of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly), diagnosis of diabetes mellitus (type 1 or type 2), glycosylated hemoglobin (HbA1c) ≤12% at screening, non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) in the study eye at screening with NPDR level 47 or level 53, as determined by the Central reading center (CRC) by using the DR severity scale (DRSS), best corrected visual acuity ETDRS letter score ≥70 letters in the study eye at screening, media clarity, pupillary dilation and individual cooperation sufficient for adequate retinal examination including fundus photographs and Optical Coherence Tomography (OCT), signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Exclusion Criteria: Cataract surgery performed within 6 months prior to screening or planned during the trial, or any additional eye disease in the study eye that, in the opinion of the investigator, could compromise or alter visual acuity during the course of the study (e.g. vein occlusion, uncontrolled intraocular pressure (IOP) >24 mmHg on optimal medical treatment, glaucoma with visual field loss, uveitis or other ocular inflammatory disease, vitreomacular traction, monocular vision, history of ischemic optic neuropathy, or genetic disorders such as retinitis pigmentosa), active center-involved DME (CI-DME) on clinical examination and Optical Coherence Tomography (OCT) central subfield thickness above 300 μm in the study eye, as measured by Optovue Optical Coherence Tomography (OCT) Heidelberg OCT, anterior segment and vitreous abnormalities in the study eye that would compromise the adequate assessment of the best corrected visual acuity or an adequate examination of the posterior pole, evidence of neovascularization on clinical examination including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization in the study eye, ruled out by gonioscopy (documented in the last 4 weeks before screening or performed at screening), prior pan-retinal photocoagulation (defined as ≥100 burns placed previously outside of the posterior pole) in the study eye, history of DME or DR treatment with macular laser within 3 months prior to screening, or intraocular injections of medication within 6 months prior to screening, and no more than 4 prior intraocular injections in the study eye at any time in the past, patients treated with Monoamine Oxidase (MAO) inhibitors or drugs that may have potential side effects due to MAO inhibition, current or planned, during the trial, use of medications known to be toxic to the retina, lens or optic nerve, or cause vision loss, patients who must or wish to continue the intake of other restricted medications or any drug considered likely to interfere with the safe conduct of the trial, estimated Glomerular filtration rate (eGFR) <60 mL/min/1.73m2 calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening, or where the investigator expects filtration rate is likely to drop below 60 mL/min/1.73m2 during the trial, alanine transaminase (ALT) or aspartate transaminase (AST) greater than 2.0-fold the upper limit of normal, or total bilirubin >1.5x upper limit of normal, uncontrolled arterial hypertension defined as a single measurement of systolic blood pressure >180 mmHg, or two consecutive measurements of systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg on optimal medical regimen at screening. If blood pressure is brought to ≤160/100 mmHg by antihypertensive treatment until randomization, individual can become eligible, Wolff-Parkinson-White Syndrome, baseline QTc >450 ms, family history of long QT, or on medication prolonging QT time at screening or planned initiation during the trial, diagnosis of a serious or unstable systemic or eye disease and other conditions that, in the clinical judgment of the investigator, are likely to interfere with the analyses of safety and efficacy in this study. Patients with an expected life expectancy of less than 2 years are also excluded, active known or suspected chronic or relevant acute infections, such as HIV (Human Immunodeficiency Virus)\viral hepatitis, or tuberculosis. QuantiFERON TB test and HBs Ag test will be performed during screening. Patients with a positive test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active infection, any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix, chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable study participant or unlikely to complete the trial, known hypersensitivity to any component of the trial drug and/or allergy to fluorescein dye, major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned during the trial, e.g. hip replacement, currently enrolled in another investigational drug trial, or less than 30 days or 5 times half-life of the investigational drug, whichever is longer, since ending another investigational drug trial from the screening visit in this trial or receiving other investigational treatment(s); patients participating in a purely observational trial will not be excluded, previous randomization in this trial, women who are pregnant, nursing, or who plan to become pregnant while in the trial, any other clinical condition that, in the opinion of the investigator, would jeopardize patient safety while participating in this clinical trial.
Study: Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)
ClinicalTrials.gov Identifier: NCT03466099
Sponsor: KalVista Pharmaceuticals, Ltd.
Purpose: This is a clinical study where patients with diabetes and a vision threatening eye condition called "Diabetic Macular Edema" receive four injections into the eye at monthly intervals. The patients will already have tried the standard of care without complete success. The patients will be randomized to receive either a high dose, a low dose or a sham control treatment. The study will evaluate whether the new treatment improves vision and whether it changes the underlying course of the disease in the eye.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 123
Inclusion Criteria: Confirmed diagnosis of Type I or Type II diabetes mellitus (DM). BCVA of ≤73 letters (~20/40 or worse) in the study eye and ≥34 letters (~20/200 or better) in the fellow eye. Presence of ciDME in the study eye defined as CST ≥305 μm in women and ≥320 μm in men. Subjects first anti-VEGF injection in the study eye occurred ≤24 months.
Subjects have received at least 3 anti-vascular endothelial growth factor (VEGF) injections in the study eye within a 5-month period. The last anti-VEGF injection in the study eye is ≥8 weeks.
Exclusion Criteria: Evidence of ocular pathology (e.g. visually significant cataract) that impacts subject's vision in the study eye from any cause other than DME. Evidence/presence of amblyopia, vitreomacular traction, epiretinal membrane, foveal atrophy, or foveal ischemia, or any other condition in the macula that is thought to impair the subject's vision (other than DME). Prior treatment with panretinal photocoagulation or focal grid macular photocoagulation in the study eye within the previous 3 months. Prior treatment with intravitreal (IVT) steroid in the study eye (in the previous 3 months for triamcinolone, previous 6 months for Ozurdex and at any time for Iluvien). Prior treatment with topical NSAIDs or topical steroids in the study eye within 1 month. Prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within 3 months. Prior vitrectomy in the study eye. Prior intraocular surgery in the study eye except for cataract surgery. Cataract surgery within the previous 6 months in the study eye is excluded. Intraocular pressure (IOP) of >22 mmHg in the study eye or use of >2 antiglaucoma agents (combination agents count as 2 agents) in the study eye. Evidence of infectious dacrocystitis, significant blepharitis, active conjunctivitis, infectious keratitis, or scleritis in either eye, or any other condition that might affect the safety of the IVT injection. Current active proliferative diabetic retinopathy (PDR), active anterior segment neovascularization (ASNV), active retinal neovascularization, or the presence of vitreous hemorrhage in the study eye. Poorly controlled DM. Uncontrolled hypertension.
Information: KVD001@kalvista.com
Study: EVADE: Variable Interval Versus Set Interval Aflibercept for DME
ClinicalTrials.gov Identifier: NCT02392364
Sponsor: California Retina Consultants
Purpose: The purpose of this study is to compare the safety and efficacy of intravitreal Eylea injections at a set interval, versus a variable dosing schedule (likely longer than one month), based on a specific individual's disease progression. There will be approximately 50 men and women at least 18 years of age, diagnosed with type 1 or type 2 diabetes, taking part in this study at 5 locations in the United States.
Design: Randomized, single group, no masking
Number of Patients: 50
Inclusion Criteria: Adults 18 years and older with Type 1 or Type 2 diabetes mellitus; patients with diabetic macular edema involving the center of the macular in the study eye (CST must measure at least 350µm on Heidelberg SDOCT, or 333µm on Cirrus SDOCT); decrease in vision determined to be primarily due to DME in the study eye; BCVA ETDRS letter score 78 to 24 (20/32 to 20/320) in the study eye; willing and able to comply with clinical visits and study related procedures; willing and able to provide signed informed consent.
Exclusion Criteria: History of vitreoretinal surgery in the study eye; Laser photocoagulation (panretinal or macular) in the study eye within 90 days of baseline; Previous use of intraocular or periocular corticosteroids in the study eye within 90 days of baseline; History of intravitreal anti-VEGF treatments in the study within 90days prior to baseline (not including prior intravitreal aflibercept injection [see exclusion criteria #5]); Any history of intravitreal aflibercept; Active proliferative diabetic retinopathy (PDR) in the study eye; History of idiopathic or autoimmune uveitis in the study eye; Cataract surgery in the study eye within 90 days of baseline; Aphakia in the study eye; Yttrium aluminum garnet (YAG) capsulotomy in the study eye within 30 days of baseline; Any intraocular surgery in the study eye within 90 days of day 1; Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect central vision; Current iris neovascularization, vitreous hemorrhage, or traction retinal detachment in the study eye; Pre-retinal fibrosis involving the macula in the study eye; Uncontrolled glaucoma (defined as any patient who has had filtration surgery in the past, or likely to need filtration surgery in the future, or has IOP ≥30mmHg); Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of ≥-8 diopters; Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause); Ocular media of insufficient quality to obtain fundus and SDOCT images; Current treatment for a systemic infection; Administration of systemic anti-angiogenic agents within 180 days of baseline; Uncontrolled diabetes mellitus, in the opinion of the investigator; Uncontrolled blood pressure (define as systolic >180mmHg, or diastolic >110mmHg while patient is sitting); History of CVA or MI within 180 days of baseline; Renal failure requiring dialysis or renal transplant; Known serious allergy to fluorescein; Participation in an investigational study within 30 days prior to baseline that involved treatment with any drug (excluding vitamins and minerals) or device; Any women who are pregnant, breast-feeding, or attempting to become pregnant.
Study: A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
ClinicalTrials.gov Identifier: NCT03397264
Sponsor: Opthea Limited
Purpose: A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 117
Inclusion Criteria: History of diabetic macular edema (DME) ≤1 year; persistent DME despite prior intravitreal anti-VEGF-A therapy with a sub-optimal response; three or more prior anti-VEGF-A therapy intravitreal injections; EDTRS BCVA score ≤73 and ≥24 letters.
Exclusion Criteria: Ocular disorders or ocular treatments which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye; HbA1c ≥12% and/or recent signs of uncontrolled diabetes; any clinically significant disorder or condition or disease (e.g. cardiovascular, renal conditions) that would make the participant unsuitable for the study.
Information: info@opthea.com
Study: DRCR.Net Aflibercept vs. Bevacizumab + Deferred Aflibercept for the Treatment of CI-DME (DRCR AC)
ClinicalTrials.gov Identifier: NCT03321513
Sponsor: Jaeb Center for Health Research
Purpose: To compare the efficacy of intravitreous aflibercept with intravitreous bevacizumab + deferred aflibercept if needed in eyes with CI DME and moderate vision loss.
Design: Randomized, parallel assignment, double masking
Number of Patients: 260
Inclusion Criteria: Best corrected Electronic-Early Treatment Diabetic Retinopathy Study visual acuity letter score <69 (i.e., 20/50 or worse) and ≥24 (i.e., 20/320 or better) within eight days of randomization. On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula. Diabetic macular edema present on optical coherence tomography (OCT) within eight days of randomization; Zeiss Cirrus central subfield: ≥290µm in women or ≥305µm in men; Heidelberg Spectralis central subfield: ≥305µm in women or ≥320µm in men; investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate fundus photographs.
Exclusion Criteria: Macular edema is considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema. An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition). An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.). Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal). History of an anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) in the past 12 months or history of any other treatment for DME at any time in the past four months (such as focal/grid macular photocoagulation, intravitreous or peribulbar corticosteroids). Enrollment will be limited to a maximum of 25% of the planned sample size with any history of anti-VEGF treatment for DME. Once this number of eyes has been enrolled, any history of anti-VEGF treatment for DME will be an exclusion criterion. History of pan-retinal photocoagulation within four months prior to randomization or anticipated need for pan-retinal photocoagulation in the six months following randomization. History of anti-VEGF treatment for a disease other than DME in the past 12 months. History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior four months or anticipated within the next six months following randomization. History of YAG capsulotomy performed within two months prior to randomization. Aphakia. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis. Evidence of uncontrolled glaucoma.
Study: IAI for Persistent DME After Treatment With Bevacizumab And Ranibizumab (ROTATED)
ClinicalTrials.gov Identifier: NCT03340610
Sponsor: Southeast Retina Center, Georgia
Purpose: This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled.
Design: Single Assignment, No Masking, Treatment
Number of Patients: 30
Inclusion Criteria: 1. Adults with Diabetes Mellitus 2. Documented history of ROTATE study completion (within 3 months +/- 1 week of exit visit) 3. BCVA ETDRS visual acuity letter score 20/25-20/400 4. Thickening due to DME involving the center of the macula evident on clinical exam 5. DME on OCT at baseline (>305 microns if male or >290 microns if female) as assessed on Heidelberg Spectralis SD OCT 6. At least 30 days but less than 45 days since prior 0.3 mg ranibizumab injection 7. Willing and able to comply with clinic visits and study-related procedures 8. Provide signed HIPAA statement and informed consent prior to any study procedures.
Exclusion Criteria: Macular edema considered to be due to a cause other than DME (ERM, Vein Occlusion, Postop CME, uveitis). History of PRP within 3 months prior to enrollment or anticipated need for PRP. History of idiopathic or autoimmune uveitis in the study eye. Cataract surgery in the study eye within 90 days of baseline. Any intraocular surgery within 90 days of baseline. Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect vision. Clinically significant pre-retinal fibrosis involving the macula in the study eye per investigator judgment. Intraocular inflammation of trace or above in the study eye. Evidence of active infection in either eye. Uncontrolled glaucoma in the study eye defined as a pressure of >25 on maximal medical therapy. Concurrent disease in the study eye, other than DME, that could compromise VA, require medical or surgical intervention during the study or could confound interpretation of the results; ocular media of insufficient quality to obtain fundus and OCT images; current treatment for a serious systemic infection; administration of systemic anti-angiogenic agents within 180 days of screen. History of YAG capsulotomy within 1 month prior to enrollment. Receipt of any treatment for DME, other than ranibizumab 0.3 mg, in the study eye at any time in the past 3 months following ROTATE study exit, (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids or other anti-VEGF agents such as Macugen, 2 mg IAI, 0.5 mg ranibizumab, or intravitreal bevacizumab). Any women who are pregnant, breast-feeding, or attempting to become pregnant. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly). Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Information: dmarcus@southeastretina.com, allison@southeastretina.com
Study: ROBIN: A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.
ClinicalTrials.gov Identifier: NCT03238963
Sponsor: Boehringer Ingelheim
Purpose: To evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47) or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without Center-involved diabetic macular edema (CI-DME).
Design: Randomized, Parallel Assignment, Double Blind, Treatment
Number of Patients: 100
Inclusion Criteria: Diagnosis of diabetes mellitus (type 1 or type 2); documented diabetes by American Diabetes Association and/or World Health Organization criteria, Antidiabetic medication stable for
Exclusion Criteria: Additional eye disease in the study eye that, in the opinion of investigator, could compromise or alter visual acuity during the course of the study (eg, vein occlusion, uncontrolled IOP >24 mmHg on optimal medical treatment, glaucoma with visual field loss, uveitis or other ocular inflammatory disease, vitreomacular traction, monocular vision, history of ischemic optic neuropathy, or genetic disorders such as retinitis pigmentosa).
Information: (800)243-0127, clintriage.rdg@boehringer-ingelheim.com
Study: Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3 mg Lucentis
ClinicalTrials.gov Identifier: NCT03097068
Sponsor: Louis C. Glazer, MD
Purpose: The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3 mg Lucentis.
Design: Single Group, No Masking, Basic Science
Number of Patients: 10
Inclusion Criteria: Diagnosis of diabetes mellitus; BCVA 20/32 to 20/320; diabetic macular edema involving the center of the macula; optical coherence tomography central subfield thickness of at least 250 microns.
Exclusion Criteria: History of anti-vascular endothelial growth factor treatment in the past 12 months; any diabetic macular edema treatment in the past 4 months; heart attack, stroke, transient ischemic attack or acute congestive heart failure within 4 months.
Information: research@vrapc.com
Study: PROMISE: Prevention of Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery
ClinicalTrials.gov Identifier: NCT01988246
Sponsor: Rishi Singh
Purpose: To determine the safety and efficacy of intravitreal Aflibercept (Eylea) injection in patients with diabetic retinopathy in the prevention of macular edema following cataract surgery.
Design: Randomized, Single Group, Single-Blind, Prevention
Number of Patients: 30
Inclusion Criteria: A cataract patient age 18 or older, planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens into the lens capsule; history of Type I or Type II diabetes; NPDR: nonproliferative diabetic retinopathy (mild, moderate, or severe) or inactive proliferative disease in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale; willing and able to comply with clinic visits and study-related procedures; patients must be able to understand and sign an informed consent that has been approved by an Institutional Review Board (IRB); central subfield macular thickness ≤320 μm in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center; absence of clinically significant macular edema (CSME) in the study eye as detected by clinical exam; patients must have visual acuity of 20/20 to 20/200.
Exclusion Criteria: Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by reading center or investigator; current or previous ocular disease in the study eye that in the opinion of the investigator may confound assessment of the macula, the retina, or central vision other that diabetic retinopathy; active proliferative diabetic retinopathy in the study eye; planned multiple procedures for study eye during the cataract/IOL implantation surgery (eg, trabeculectomy, corneal transplant); patients who have received corneal transplants in the study eye; patients with current or history of chronic or recurrent ocular infections or inflammation in the study eye; patients with a visually nonfunctional fellow eye based upon the assessment by the investigator; patients who are immunocompromised (eg, patients receiving chemotherapy irradiation therapy, patients with AIDS, leukemia, or cachexia) or patients receiving dialysis; use of medications known to affect the macula, including hydroxychloroquinine (Plaquenil) and phenothiozines (eg, thioridazine [Mellaril], chloropromazine [Thorazine]) or supplemental niacin ≥3 grams/day; use of systemic steroids, NSAIDS (nonsteroidal anti-inflammatory drugs), anti-VEGF agents within 7 days prior to surgery (through study exit). Daily doses of aspirin, up to 325 mg, will be permitted; use of topical ocular NSAIDS and steroids, in the study eye, within 7 days prior to surgery; treatment with intraocular or periocular steroids in the study eye within 3 months prior to surgery; focal photocoagulation for the treatment of diabetic macular edema in the study eye within 6 months of the pre-operative baseline visit (Note: peripheral retina treatment for retinal tear or lattice degeneration is permitted); intravitreal anti-VEGF (vascular endothelial growth factor) treatment in the study eye within 6 months of the pre-operative baseline visit; patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication; use of a topical ophthalmic prostaglandin (eg, TRAVATAN, XALATAN) within 4 days of surgery through study exit; any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could require either medical or surgical intervention during the 90 day study period; any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety; pregnant or breast-feeding women.
Information: singhr@ccf.org, mcowend@ccf.org
Study: Continuation of Previous Study to Gather More Data on Effect of Macugen on the Corneal Endothelium
ClinicalTrials.gov Identifier: NCT01573572
Sponsor: Valeant Pharmaceuticals International
Purpose: Due to the lack of information generated in the pivotal phase III trials assessing potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium, the FDA requested clinical information from a 1-year (minimum) clinical study to support that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Design: Single Group, Open Label
Number of Patients: 125
Inclusion Criteria: Subjects aged 50 years or older and diagnosed with subfoveal neovascular AMD, DME, or Retinal Vein Occlusion; best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/20 and 20/400 using a Snellen chart; women must be using 2 forms of effective contraception, be post-menopausal for at least 12 months prior to study entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The 2 forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication; provide written informed consent; ability to return for all study visits.
Exclusion Criteria: Unilateral ocular blunt trauma within 1 year of enrollment and no greater than 5% difference in central endothelial cell density between the 2 eyes; intraocular surgery (cataract surgery and surgery for glaucoma without tube shunt or mini-shunt) within 1 year of enrollment; anterior segment laser surgery (laser trabeculoplasty) performed within 1 year of enrollment; glaucoma tube-shunt surgery; previous history of corneal transplant in the study or nonstudy eye; presence of vitreous macular traction; previous therapeutic radiation in the region of the study eye; any treatment with an investigational agent in the past 30 days for any condition; known serious allergies to the components of pegaptanib sodium formulation. Any of the following underlying diseases, including: History or evidence of severe cardiac disease(eg, NYHA Functional Class III or IV - see Appendix 2), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrhythmias requiring ongoing treatment; history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation; history or evidence of clinically significant impaired renal or hepatic function; stroke (within 12 months of study entry); any major surgical procedure within one month of study entry; significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity; subjects should not be entered if there is likelihood that they will require cataract or glaucoma surgery in either eye during the study treatment and follow-up period.
Information: denise.raimondo@valeant.com
Study: SwapTwo: Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab
ClinicalTrials.gov Identifier: NCT02559180
Sponsor: Rishi Singh, MD, Cleveland Clinic Foundation/Regeneron
Purpose: To evaluate the safety and efficacy of treatment of diabetic macular edema with intravitreal aflibercept in subjects previously treated with intravitreal anti-VEGF agents (ranibizumab or bevacizumab).
Design: Single Group, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Foveal-involving retinal edema secondary to DME based on investigator review of clinical exam and SD-OCT with central subfield thickness value of 325 microns by Zeiss Cirrus SD-OCT; E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye; history of previous treatment with anti-VEGF with at least 4 injections over the last 6 months.
Exclusion Criteria: Any prior or concomitant therapy with another investigational agent to treat DME in the study eye; prior panretinal photocoagulation in the study eye within the past 3 months; prior intravitreal anti-VEGF therapy in the study eye within 30 days of enrollment; prior systemic anti-VEGF therapy, investigational or FDA-approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study; previous treatment with intravitreal aflibercept injection; significant vitreous hemorrhage obscuring view to the macula or the retinal periphery as determined by the investigator on clinical exam.
Information: mcowend@ccf.org, singhr@ccf.org, borera@ccf.org
Study: The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates
ClinicalTrials.gov Identifier: NCT02448446
Sponsor: South Coast Retina Center; Carson, McBeath, Boswell, Inc.
Purpose: This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
Design: Randomized, Parallel Assignment, Open Label, Treatment
Number of Patients: 25
Inclusion Criteria: Age 18 or older; Type 1 or Type 2 diabetes mellitus; best corrected ETDRS visual acuity (20/32-20/320) or letter score 78 to 24; diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss; retinal thickness measured on spectral domain optical coherence tomography (OCT). Zeiss Cirrus: ≥290 um in women and ≥305 um in men in the central subfield. Heidelberg Spectralis: ≥305 um in men in the central subfield; lipid exudates involving the central subfield on spectral domain OCT.
Exclusion Criteria: Treatment for diabetic macular edema within the prior 4 months; panretinal photocoagulation within the prior 4 months or anticipated need for panretinal photocoagulation within the next 6 months; major ocular surgery within the prior 4 months; myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack, or treatment for acute congestive heart failure occurred within 4 months before randomization; pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraception (the following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device [IUD], or contraceptive hormone implant or patch); any other condition the investigator believes would pose a significant hazard to the subject; participation in another simultaneous medical investigation or trial.
Information: jgasperinimd@southcoastretina.com, jbecerra@southcoastretina.com
Study: Protocol V: Treatment for CI-DME in Eyes With Very Good VA Study
ClinicalTrials.gov Identifier: NCT01909791
Sponsor: Jaeb Center for Health Research
Purpose: To compare the % of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better.
Design: Randomized, Safety/Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 702
Inclusion Criteria: Best corrected E-ETDRS visual acuity letter score ≥79 (approximate Snellen equivalent 20/25 or better) at 2 consecutive visits within 1 to 28 days; on clinical exam, definite retinal thickening due to DME involving the center of the macula; diabetic macular edema confirmed on OCT (equivalent to CSF thickness on OCT ≥250 microns on Zeiss Stratus or gender-specific spectral domain OCT equivalent) at 2 consecutive visits within 1 to 28 days. (a) Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality.
Exclusion Criteria: Macular edema is considered to be due to a cause other than DME. An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (eg, a taut posterior hyaloid or epiretinal membrane) are contributing to the macular edema; an ocular condition is present such that, in the opinion of the investigator, any visual acuity loss would not improve from resolution of macular edema (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition); an ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (eg, vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
Information: www.jaeb.org
Study: Anti-VEGF Treatment for Prevention of PDR/DME
ClinicalTrials.gov Identifier: NCT02634333
Sponsor: Jaeb Center for Health Research
Purpose: To determine the efficacy and safety of intravitreous aflibercept injections vs sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications.
Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-Blind, Prevention
Number of Patients: 322
Inclusion Criteria: No evidence of neovascularization on clinical exam including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization (if the angle is assessed); no evidence of neovascularization (NV) on fluorescein angiography within the 7-modified ETDRS fields, confirmed by the central Reading Center prior to randomization. The widest method of imaging available at the site must be used to document whether there is NV present in the periphery; however, presence of NV outside of the 7-modified ETDRS fields on ultrawide field imaging will not be an exclusion provided treatment is not planned; no center-involved diabetic macular edema (CI-DME) on clinical exam and optical coherence tomography (OCT) central subfield thickness must be below the following gender and OCT-machine specific thresholds.
Exclusion Criteria: Exam or photographic evidence of vitreous or preretinal hemorrhage presumed to be from PDR; history of prior vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR; history of prior PRP (defined as ≥100 burns outside of the posterior pole); an ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (eg, retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, vitreomacular traction, etc.).
Information: www.jaeb.org
Study: DIME: Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema
ClinicalTrials.gov Identifier: NCT02471651
Sponsor: Allergan/California Retinal Consultants
Purpose: To compare the effectiveness of using a dexamethasone steroid implant vs monthly intravitreal anti-VEGF injections for research participants with persistent diabetic macular edema.
Design: Randomized, Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: Clinical evidence of retinal thickening due to macular edema involving the center of the macula associated with diabetic retinopathy; previous history of anti-VEGF treatment for diabetic macular edema (DME) with documented incomplete resolution of central subfield thickening by spectral-domain optical coherence tomography (SD-OCT). At least 4 intravitreal anti-VEGF injections within the past 6 months prior to the baseline study visit are required for eligibility; central diabetic macular edema present on clinical examination and SD-OCT testing with central 1 mm subfield thickness greater than 300 microns as measured on SD-OCT at the baseline visit; visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 74 letters (20/32) by the ETDRS visual acuity protocol.
Exclusion Criteria: An eye that, in the investigator’s opinion, has no chance of improving in visual acuity following resolution of macular edema (eg, presence of subretinal fibrosis or geographic atrophy); presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (eg, AMD, uveitis, Irvine-Gass); evidence of active neovascularization of the iris or retina; evidence of central atrophy or fibrosis in the study eye; presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at some time during the study; history of vitreous surgery in the study eye.
Information: sarahf@californiaretina.com, gabe@californiaretina.com
RETINAL VEIN OCCLUSION
Study: TOPAZ: Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
ClinicalTrials.gov Identifier: NCT03203447
Sponsor: Clearside Biomedical, Inc.
Purpose: This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 460
Inclusion Criteria: Has a clinical diagnosis of RVO in the study eye, has a CST of ≥300 µm in the study eye, has an ETDRS BCVA score of ≥20 letters read and ≤70 letters read in the study eye, is naïve to local pharmacologic treatment for RVO in the study eye.
Exclusion Criteria: Any active ocular disease or infection in the study eye other than RVO, history of glaucoma, intraocular pressure >21 mmHg or ocular hypertension requiring more than one medication, any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study, any evidence of neovascularization in the study eye.
Information: kathleen.billman@clearsidebio.com, nichole.wilkes@clearsidebio.com
Study: Minocycline to Treat Central Retinal Vein Occlusion
ClinicalTrials.gov Identifier: NCT01468844
Sponsor: National Eye Institute (NEI)
Purpose: To test the safety and effectiveness of minocycline as a treatment for central retinal vein occlusion.
Design: Parallel assignment, double masked, treatment
Number of Patients: 20
Inclusion Criteria: The study eye has a best-corrected ETDRS visual acuity score between 78 and 34 letters (i.e., between 20/32 and 20/200). The study eye shows definite retinal thickening due to a CRVO based on clinical examination involving the center of the macula that is not refractory to further therapy as based on the investigator s clinical judgment. CRVO is defined as an eye that had retinal hemorrhage or other biomicroscopic evidence of RVO (e.g., telangiectatic capillary bed) and a dilated (or previously dilated) venous system in at least three quadrants of the retina drained by the affected vein. The study eye has retinal thickness in the central subfield on baseline OCT measurement >350 microns, as measured by Zeiss Cirrus spectral domain OCT, or an equivalent retinal thickness on a similar OCT machine. The study eye has media clarity and pupillary dilation sufficient for adequate fundus photographs. Furthermore, the participant must be able to cooperate during the procedure for accurate fundus photographs.
Exclusion Criteria: Macular edema is considered to be due to a cause other than CRVO. An eye should not be considered eligible if: The macular edema is considered to be related to cataract extraction or clinical examination and/or OCT suggest that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema. Clinical examination, medical history and/or fluorescein angiography suggest that diabetic retinopathy is the primary cause of the edema. The study eye has a history of a recurrent RVO. The study eye has a history of RVO present for >18 months. A brisk afferent pupillary defect (APD) is present in the study eye. An ocular condition (other than RVO) is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, laser scar at fovea, non-retinal condition). An ocular condition (other than RVO) is present that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.). A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal) is present in the study eye. The study eye has had panretinal or sectoral scatter photocoagulation (PRP) within four months prior to study entry. The study eye has had pars plana vitrectomy within six months prior to study entry. The study eye has undergone major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within three months prior to study entry. A yttrium aluminum garnet (YAG) capsulotomy has been performed on the study eye within two months prior to study entry. The study eye has had treatment <3 months prior to study entry of intravitreal or periocular steroid injections. The study eye has had treatment <28 days prior to study entry of intravitreal anti-VEGF agents.
Information: chenfa@nei.nih.gov, cukrasc@mail.nih.gov
Study: Minocycline to Treat Branch Retinal Vein Occlusion
ClinicalTrials.gov Identifier: NCT01468831
Sponsor: National Eye Institute (NEI)
Purpose: To test the safety and effectiveness of minocycline as a treatment for branch retinal vein occlusion (BRVO).
Design: Parallel Assignment, Double-Blind, Treatment
Number of Patients: 20
Inclusion Criteria: Foveal center-involved macular edema secondary to a BRVO, retinal thickness in the central subfield >350 microns as measured by optical coherence tomography and visual acuity between 20/32 and 20/200 in the study eye.
Exclusion Criteria: The study eye has macular edema considered to be due to a cause other than BRVO; study eye has history of recurrent RVO or RVO present for >18 months; ocular conditions present such that visual acuity would not improve with resolution of macular edema or that would affect visual acuity; substantial cataract; study eye has undergone recent panretinal or sectoral scatter photocoagulation or pars plana vitrectomy; recent ocular surgery.
Information: angela.kibiy@ nih.gov, cukrasc@mail.nih.gov
Study: Continuation of Previous Study to Gather More Data on Effect of Macugen on the Corneal Endothelium
ClinicalTrials.gov Identifier: NCT01573572
Sponsor: Valeant Pharmaceuticals International
Purpose: Due to the lack of information generated in the pivotal phase III trials assessing potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium, the FDA requested clinical information from a 1-year (minimum) clinical study to support that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Design: Single Group, Open Label
Number of Patients: 125
Inclusion Criteria: Subjects aged 50 years or older and diagnosed with subfoveal neovascular AMD, DME, or Retinal Vein Occlusion; best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/20 and 20/400 using a Snellen chart; women must be using 2 forms of effective contraception, be post-menopausal for at least 12 months prior to study entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The 2 forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication; provide written informed consent; ability to return for all study visits.
Exclusion Criteria: Unilateral ocular blunt trauma within 1 year of enrollment and no greater than 5% difference in central endothelial cell density between the 2 eyes; intraocular surgery (cataract surgery and surgery for glaucoma without tube shunt or mini-shunt) within 1 year of enrollment; anterior segment laser surgery (laser trabeculoplasty) performed within 1 year of enrollment; glaucoma tube-shunt surgery; previous history of corneal transplant in the study or nonstudy eye; presence of vitreous macular traction; previous therapeutic radiation in the region of the study eye; any treatment with an investigational agent in the past 30 days for any condition; known serious allergies to the components of pegaptanib sodium formulation. Any of the following underlying diseases, including: History or evidence of severe cardiac disease(eg, NYHA Functional Class III or IV - see Appendix 2), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrhythmias requiring ongoing treatment; history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation; history or evidence of clinically significant impaired renal or hepatic function; stroke (within 12 months of study entry); any major surgical procedure within one month of study entry; significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity; subjects should not be entered if there is likelihood that they will require cataract or glaucoma surgery in either eye during the study treatment and follow-up period.
Information: denise.raimondo@valeant.com
Study: SAPPHIRE: Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
ClinicalTrials.gov Identifier: NCT02980874
Sponsor: Clearside Biomedical, Inc.
Purpose: This is a phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months’ duration in treatment naïve subjects with RVO.
Design: Randomized, Parallel Assignment, Triple-Blind, Treatment
Number of Patients: 460
Inclusion Criteria: Has a clinical diagnosis of RVO in the study eye; has a CST of ≥300 µm in the study eye; has an ETDRS BCVA score of ≥20 letters read and ≤70 letters read in the study eye; is naïve to local pharmacologic treatment for RVO in the study eye.
Exclusion Criteria: Any active ocular disease or infection in the study eye other than RVO; history of glaucoma, intraocular pressure >21 mmHg or ocular hypertension requiring more than one medication; any uncontrolled systemic disease that, in the opinion of the investigator, would preclude participation in the study; any evidence of neovascularization in the study eye.
Information: kathleen.billman@clearsidebio.com, nichole.wilkes@clearsidebio.com
UVEITIS
NEW Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis
ClinicalTrials.gov Identifier: NCT03066869
Sponsor: Ocular Immunology and Uveitis Foundation
Purpose: The purpose of this study is to evaluate the short- and long-term efficacy and safety of Acthar for the treatment of adults with non-infectious retinal vasculitis.
Design: Single group assignment, no masking
Number of Patients: 20
Inclusion Criteria: Any adult patient with active retinal vasculitis (involving arteries or veins) as a manifestation of non-infectious ocular inflammatory disease; fundus must be viewable with wide-field FA in the study eye. If both eyes are involved, both are eligible for inclusion in the study. Patients already on non-steroidal immunosuppressive therapy may continue on this during the study, but the dose must not be increased or decreased within 6 weeks of initiating the trial. Willing and able to sign the informed consent form.
Exclusion Criteria: Patients under age 18. Patients who are pregnant (must be ruled out in women of child-bearing age). Active infectious ocular or systemic disease. Patients with active infectious ocular or extraocular disease. Patients with history of malignancy, except for dermatologic entities of basal or squamous cell carcinoma which have been completely excised or removed previously. Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction. Patients with known hypersensitivity to Acthar. Patients on other non-steroidal systemic immunomodulatory medications with dose adjusted sooner than 6 weeks prior to study drug administration. Patients currently on or recently treated with (within 6 weeks) systemic corticosteroid. Patients with periocular or intraocular injections of medications administered to help control inflammation sooner than 6 weeks prior to study drug administration. Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator, or contraindicated, including but not limited to, patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin. Administration of live or live attenuated vaccines is contraindicated in patients during the entire duration of the study and for one month prior.
Study: Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
ClinicalTrials.gov Identifier: NCT01694186
Sponsor: pSivida Corp.
Purpose: This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment.
Design: Randomized, parallel assignment, double masking
Number of Patients: 129
Inclusion Criteria: Male or non-pregnant female at least 18 years of age at time of consent. One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis >1 year duration. At the time of enrollment (Day 1), study eye has <10 anterior chamber cells/HPF and a vitreous haze ≤grade 2. Visual acuity of study eye is at least 15 letters on the ETDRS chart. Subject is not planning to undergo elective ocular surgery during the study. Subject has ability to understand and sign the Informed Consent Form. Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. During the 12 months prior to enrollment (Day 1), the study eye has either received treatment: systemic corticosteroid or other systemic therapies given for at least 3 months, and/or at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis OR the study eye has experienced recurrence: at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid.
Exclusion Criteria: Allergy to fluocinolone acetonide or any component of the FAI insert. History of posterior uveitis only that is not accompanied by vitritis or macular edema. History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze. Uveitis with infectious etiology. Vitreous hemorrhage. Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma). Ocular malignancy in either eye, including choroidal melanoma. Toxoplasmosis scar in study eye or scar related to previous viral retinitis. Previous viral retinitis. Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures. Media opacity precluding evaluation of retina and vitreous. Peripheral retinal detachment in area of insertion. Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmHg). Intraocular pressure (IOP) >21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye. Chronic hypotony (<6 mmHg). Ocular surgery on the study eye within 3 months prior to study Day 1. Capsulotomy in study eye within 30 days prior to study Day 1. Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1. Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1. Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1. Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1. Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy. Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1. Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis. Systemic infection within 30 days prior to study Day 1. Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study. Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study. Treatment with an investigational drug or device within 30 days prior to study Day 1. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit. Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years.
Study: Study of the Effectiveness of Ozurdex for the Control of Uveitis
ClinicalTrials.gov Identifier: NCT02049476
Sponsor: Johns Hopkins University
Purpose: The main purpose of this study is to evaluate whether or not the dexamethasone pellet (Ozurdex, Allergan, Irvine, CA) can replace oral corticosteroid (e.g. prednisone) in the treatment of active sight-threatening, noninfectious intermediate and/or posterior uveitis in which immunosuppressive drug therapy is indicated.
Design: Single group, no masking
Number of Patients: 20
Inclusion Criteria: Active sight-threatening intermediate or posterior uveitis for which immunosuppressive drug therapy is planned and the physician is considering treatment with high-dose corticosteroid to control the uveitis whilst immunosuppressive drugs are being instituted or adjusted. Note: it is acceptable for the patient to already be on an immunosuppressive drug as long as high dose corticosteroids are indicated.
Patients must be age 18 years or older (the dexamethasone pellet is not FDA-approved for pediatric use) and sign an informed consent.
The ocular media must be clear enough to obtain optical coherence photography (OCT) and fundus photographs.
No elective intraocular surgery should be planned for the first 3 months after enrollment.
Exclusion Criteria: Infectious uveitis; History of scleritis; Active or suspected viral infection of the cornea or conjunctiva; History of mycobacterial or fungal disease; HIV positivity; Age <18 years old; Allergy to dexamethasone; Uncontrolled IOP; Advanced glaucoma; Aphakia with rupture of the posterior lens capsule; Anterior chamber IntraOcualr Lens (ACIOL) with rupture of the posterior lens capsule; Media opacity that would preclude evaluation of the posterior pole via fundus photography or OCT assessment; Planned elective ocular surgery within 3 months of enrollment; Any systemic disease requiring systemic corticosteroids.
Information: ikhan11@jhmi.edu, jthorne@jhmi.edu
Study: SOLACE: A Phase 3 Study to Evaluate ADX-102 Ophthalmic Solution in Subjects With Non-infectious Anterior-uveitis
ClinicalTrials.gov Identifier: NCT03131154
Sponsor: Aldeyra Therapeutics, Inc.
Purpose: A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with noninfectious anterior-uveitis.
Design: Randomized, Quadruple Masking, Treatment
Number of Patients: 100
Inclusion Criteria: Male or female subjects aged ≥18 years and ≤85 years. Subjects with acute noninfectious anterior uveitis with onset of symptoms within the previous 2 weeks. Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the nonstudy eye using ETDRS testing.
Exclusion Criteria: Have severe/serious ocular pathology in the study eye(s) which may preclude study completion, in the judgement of the Investigator. Active intermediate or posterior uveitis in the study eye(s). Previous anterior uveitis episode in the study eye ≤4 weeks prior to screening. Have participated in another investigational device or drug study within 30 days prior to screening. Participation in a prior ADX-102 study.
Information: bcavanagh@aldeyra.com
Study: Humboldt: Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
ClinicalTrials.gov Identifier: NCT03207815
Sponsor: Gilead Sciences
Purpose: The primary objective of this study is to evaluate the efficacy of filgotinib vs placebo for the treatment of the signs and symptoms of noninfectious uveitis in participants failing treatment for active noninfectious uveitis.
Design: Randomized, Parallel Assignment, Double Masking, Treatment
Number of Patients: 110
Inclusion Criteria: Is diagnosed with noninfectious intermediate-, posterior-, or pan-uveitis; Must have active uveitic disease at the Day 1/Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite 2 weeks or more of maintenance therapy with oral prednisone (≥10 mg/day to ≤60 mg/day) or oral corticosteroid equivalent:
Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion; ≥2+ anterior chamber cells per the Standardization of Uveitis Nomenclature (SUN) criteria; ≥2+ vitreous haze per the National Eye Institute/Standardization of Uveitis Nomenclature (NEI/SUN) criteria. No evidence of active tuberculosis (TB), history of prior TB or latent TB meeting the screening criteria.
Exclusion Criteria: Adults with severe glaucoma at screening are not eligible to participate; severe glaucoma is defined as: Intraocular pressure of ≥25 mmHg and on ≥2 glaucoma medications and/or; Any evidence of glaucomatous optic nerve injury. Confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV). Adults with a prior failure of anti-tumor necrosis factor (TNF) therapy or previous exposure to any biologic therapy (except intravitreal anti-vascular endothelial growth factor [VEGF] therapy) with a potential therapeutic impact on noninfectious uveitis within 90 days of Day 1/ Baseline are not eligible to participate.
Information: GileadClinicalTrials@gilead.com
Study: MERIT: Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial
ClinicalTrials.gov Identifier: NCT02623426
Sponsor: JHSPH Center for Clinical Trials
Purpose: This trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6-month clinic visit. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.
Design: Randomized, Parallel Assignment, Single Masking, Treatment
Number of Patients: 240
Inclusion Criteria: 18 years of age or older; at least one eye must meet all of the following conditions; Inactive or minimally active noninfectious anterior, intermediate, posterior or panuveitis, as defined by SUN132 criteria as ≤0.5+ anterior chamber cells, ≤0.5+ vitreous haze grade and no active retinal/choroidal lesions for a minimum of 4 weeks; Macular edema (ME) defined as the presence of macular thickness greater than the normal range for the OCT machine being used (see cut points below), regardless of the presence of cysts, following an intravitreal corticosteroid injection (≥4 weeks following intravitreal triamcinolone injection or ≥12 weeks following intravitreal dexamethasone implant injection); Greater than 300 μm for Zeiss Cirrus Greater than 320 μm for Heidelberg Spectralis Greater than 300 μm for Topcon 3DOCT; Baseline fluorescein angiogram that, as assessed by the study ophthalmologist, is gradable for degree of leakage in the central subfield; Best corrected visual acuity (BCVA) 5/200 or better; Baseline intraocular pressure >5 mm Hg and ≤21 mm Hg (current use of ≤3 intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable (Note: combination medications, eg, Combigan, are counted as 2 IOP-lowering medications); Media clarity and pupillary dilation sufficient to allow OCT testing and assessment of the fundus.
Exclusion Criteria: History of infectious uveitis in either eye; History of infectious scleritis of any type in either eye (Note: History of noninfectious scleritis that has been active in past 12 months is an eye-level exclusion -see #13 below); History of keratitis (with the exception of keratitis due to dry eye) in either eye; History of central serous retinopathy in either eye; Active infectious conjunctivitis in either eye; Oral prednisone dose >10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤10 mg per day at baseline that has not been stable for at least 4 weeks (note: if patient is off of oral prednisone at baseline (M01 study visit) dose stability requirement for past 4 weeks does not apply); Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks (note: use of systemic methotrexate is acceptable as long as regimen has been stable for at least 4 weeks); Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline; Known allergy or hypersensitivity to any component of the study drugs; For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial; Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions: History of infectious endophthalmitis; History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of ≥0.9 or any notching of optic nerve to the rim); History of active noninfectious scleritis in past 12 months (Note: History of noninfectious scleritis is acceptable if the last episode of active scleritis resolved at least 12 months prior to enrollment); Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (ie, causing substantial wrinkling of the retinal surface); Torn or ruptured posterior lens capsule; Presence of silicone oil; Ozurdex administered in past 12 weeks; Anti-VEGF agent, intravitreal methotrexate, or intravitreal/periocular corticosteroid administered in past 4 weeks; Fluocinolone acetonide implant (Retisert) placed in past 3 years.
Information: jholbro1@jhu.edu, esugar2@jhu.edu
Study: STAR Study: Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis
ClinicalTrials.gov Identifier: NCT02911116
Sponsor: National Eye Institute (NEI)
Purpose: The study objective is to investigate the safety, tolerability and potential efficacy of subcutaneous injections of ustekinumab as a possible treatment for active intermediate uveitis, posterior uveitis or panuveitis.
Design: prospective, nonrandomized, uncontrolled
Number of Patients: 7
Inclusion Criteria: Participant has the ability to understand and sign the informed consent document; Participant is 18 years of age or older; Participant has negative purified protein derivative (PPD) or quantiferon testing done within 3 months prior to enrollment or had latent tuberculosis (TB) but has completed prophylactic anti-TB treatment; Participant has active intermediate uveitis, posterior uveitis or panuveitis in at least one eye requiring systemic therapy. Participant has visual acuity in at least one eye of 20/400 or better. Participant is willing and able to comply with the study procedures. Female participants of childbearing potential must not be pregnant or breast-feeding, have a negative pregnancy test at screening and must be willing to undergo pregnancy testing throughout the study. Both female participants of childbearing potential and male participants able to father a child must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice 2 effective methods of contraception throughout the course of the study and for 6 weeks after the last investigational product injection.
Exclusion Criteria: Participant has a significant active infection (an infection requiring treatment as determined by the medical team), including active tuberculosis or human immunodeficiency virus (HIV). Participant received a live vaccination within the past 6 weeks. Participant is expected to receive a live vaccination at any time during the study. Participant received the BCG vaccine within the past year. Participant is expected to receive the BCG vaccine at any time during the study or up to 1 year after discontinuing ustekinumab. Participant has a history of cancer (other than a nonmelanoma skin cancer) diagnosed within the past 5 years. Participant has received intraocular (or periocular) steroid or anti-vascular endothelial growth factor (VEGF) injections within the last 6 weeks. Participant received rituximab within the last 6 months or another biologic agent (e.g., infliximab, daclizumab, adalimumab) within the last 2 months. Participant has received alkylating agents (e.g., cyclophosphamide, chlorambucil) within the last 9 months. Participant has a known hypersensitivity to ustekinumab or any of its components.
Information: dobiyor@mail.cc.nih.gov
Study: SAVE-2: Intravitreal Sirolimus as Therapeutic Approach to Uveitis
ClinicalTrials.gov Identifier: NCT01280669
Sponsor: Stanford University, Santen Inc.
Purpose: The purpose of this study is to find out about the safety and effectiveness of 2 different doses the study drug, sirolimus, administered intravitreally in patients with uveitis.
Design: Randomized, Parallel Assignment, No Masking
Number of Patients: 30
Inclusion Criteria: >12 years of age, able to give consent, have diagnosis of uveitis, have active uveitis, defined as having at least 1+ Vitreous Haze and/or at least 1+ Vitreous Cell Count (SUN scale), and: are receiving no treatment; or are receiving: prednisone ≥10 mg/day (or equivalent dose of another corticosteroid), or at least 1 systemic immunosuppressant other than corticosteroids, or combination of prednisone ≥10 mg/day (or equivalent dose of another corticosteroid) and other systemic immunosuppressant. Have inactive disease, defined as having 0.5+ vitreous haze or less and 0.5+ or less vitreous cell count (SUN scale), and are receiving: prednisone <10 mg/day (or equivalent dose of another corticosteroid), or at least 1 systemic immunosuppressant other than corticosteroids, or combination of prednisone <10 mg/day (or equivalent dose of another corticosteroid) and other systemic immunosuppressant. Have posterior, intermediate, or panuveitis; for panuveitis, if an anterior component is present, it must be less than the posterior component. Sufficient inflammation to require systemic treatment and, based on the Investigator's decision, warrants intravitreal treatment. Best-corrected ETDRS visual acuity of 20/400 or better (approximately 20 letters) in the study eye. Best-corrected ETDRS visual acuity of 20/400 or better in the fellow eye (approximately 20 letters).
Exclusion Criteria: Patients with bilateral uveitis who are receiving systemic immunosuppressive therapy (e.g., methotrexate, cyclosporine, cyclophosphamide, chlorambucil, mycophenolate mofetil, tacrolimus, or azathioprine) other than prednisone or other corticosteroids for the treatment of uveitis and the uveitis in the fellow eye, in the opinion of the Investigator, cannot be controlled with standard local therapies alone; Any significant ocular disease that could compromise the visual outcome in the study eye. Intravitreal injections (including but not limited to anti-vascular endothelial growth factors 60 days prior to the baseline; Posterior subtenon's or intravitreal injection of steroids 90 days prior to Baseline; Intraocular surgery within 90 days prior to Day 0 in the study eye; Capsulotomy within 30 days prior to Day 0 in the study eye; History of vitreoretinal surgery or scleral buckling within 90 days prior to Day 0 in the study eye; Any ocular surgery (including cataract extraction or capsulotomy) of the study eye anticipated within the first 180 days following Day 0; Intraocular pressure ≥25 mmHg in the study eye (glaucoma patients maintained on no more than 2 topical medications with IOP <25 mmHg are allowed to participate); Pupillary dilation inadequate for quality fundus photography in the study eye; Media opacity that would limit clinical visualization, intravenous fluorescein angiography (IVFA), or OCT evaluation in the study eye; Presence of any form of ocular malignancy in the study eye, including choroidal melanoma; History of herpetic infection in the study eye or adnexa; Presence of known active or inactive toxoplasmosis in either eye; Ocular or periocular infection in either eye; Participation in other investigational drug or device clinical trials within 30 days prior to Day 0, or planning to participate in other investigational drug or device clinical trials within 180 days following Day 0. This includes both ocular and nonocular clinical trials.
Information: ndquan@stanford.edu, lgreer7@stanford.edu
Study: FAST: Methotrexate and Mycophenolate Mofetil for UVEITIS
ClinicalTrials.gov Identifier: NCT01829295
Sponsor: University of California, San Francisco
Purpose: In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial, the investigators propose to establish which immunosuppressive therapy, methotrexate or mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for the treatment of noninfectious uveitis in a block-randomized, observer-masked, comparative effectiveness trial.
Design: Randomized, Crossover Assignment, Investigator and Outcomes Assessor Masking
Number of Patients: 216
Inclusion Criteria: Historical noninfectious intermediate, anterior and intermediate, posterior or panuveitis in at least one eye. Active inflammation within the last 180 days and active inflammation at enrollment. At least one of the following: Active inflammation after 4 weeks of high-dose (1mg/kg prednisone equivalent) corticosteroid treatment or 4 weeks following a regional corticosteroid injection; Treatment with oral corticosteroids resulting in a reduction of inflammation, followed by an increase in inflammation (of at least 1 grade in anterior chamber cells or vitreous haze or a change of nonactive to active lesions) when corticosteroid is tapered, in the 180 weeks prior to enrollment; Active inflammation after long-acting corticosteroid injection 4 weeks to 180 days prior to enrollment; Active inflammation after treatment with >10mg/day oral prednisone for at least the past 90 days prior to enrollment; Known chronic condition necessitating corticosteroid-sparing immunosuppressive treatment: Behcet's disease with posterior segment involvement, multifocal choroiditis with panuveitis, serpiginous choroidopathy, birdshot retinochoroidopathy, diffuse retinal vasculitis, Vogt-Koyanagi-Harada with bullous serous retinal detachments and/or choroidal detachments, sympathetic ophthalmia. No prior therapy required for these patients.
Exclusion Criteria: Any infectious cause of uveitis; Prior immunosuppressive therapy other than corticosteroids in the past 12 months; Prior intolerability or safety issues with methotrexate or mycophenolate mofetil; Prior failure to control ocular or other inflammation using methotrexate or mycophenolate mofetil; Prior biologic therapy at any time; Media opacity (such as cataract and/or corneal scar) and/or extensive posterior synechiae such that examination of the posterior segment is not possible in both eyes; Chronic hypotony (IOP <5 mm Hg for >3 months) in both eyes; Periocular or intravitreal corticosteroid injection in the past 4 weeks; Fluocinolone acetonide implant in either eye in <3 years; Intraocular surgery in <30 days, or planning on getting surgery within the next 6 months; Best spectacle-corrected visual acuity (BSCVA) of hand motions or worse in better eye; <16 years of age at enrollment; Planning to conceive during the study period, pregnant or breast-feeding (blood or urine pregnancy test for all females, excluding those who are post-menopausal is mandatory); Any history of cancer (If a patient has a history of nonmelanoma skin cancer they can still be considered for inclusion in this study, provided it is not currently active). Systemic autoimmune disease anticipated to dictate treatment course.
Information: nisha.acharya@ucsf.edu, travis.porco@ucsf.edu
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