DRY AMD
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: BEACON: A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02087085
Sponsor: Allergan
Purpose: This study will assess the safety and efficacy of the brimonidine intravitreal implant in patients with geographic atrophy due to age-related macular degeneration.
Design: Randomized, Parallel Assignment, Triple Masking, Treatment
Number of Patients: 310
Inclusion Criteria: Geographic atrophy due to age-related macular degeneration in the study eye; Visual acuity better than or equal to 20/125 in the study eye and 20/200 in the fellow eye.
Exclusion Criteria: Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in the last 3 months; Infections in either eye in the last 3 months.
Information: www.allerganclinicaltrials.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: Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients
ClinicalTrials.gov Identifier: NCT02296567
Sponsor: East Florida Eye Institute
Purpose: To demonstrate the effects of Lucentis (ranibizumab), Avastin (bevacizumab), and Eylea (aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF) in the systemic circulation of Age Related Macular Degeneration patients currently treated with these medications.
Design: Nonrandomized, Parallel Assignment, Open Label, Basic Science
Number of Patients: 80
Inclusion Criteria: Ability to provide written, informed consent for participation; age 50 or older, with exudative macular degeneration treated with Avastin, Lucentis, or Eylea in previously determined time intervals exclusive to a single anti-VEGF treatment type for not than 3 months; CONTROL GROUP – age matched control group with no previously diagnosed exudative macular degeneration will also be enrolled
Exclusion Criteria: Uncontrolled blood pressure (defined as systolic >160mm Hg or Diastolic >95mm Hg while patient is sitting); Uncontrolled diabetes mellitus defined by Hemoglobin A1c (HbA1C >12% at screening); Concomitant ocular or systemic administration of drugs that may interfere with or potentiate the mechanism of action of anti-VEGF medications; Previous administration of systemic anti-angiogenic medications within 3 months; Participation in a simultaneous medical investigation or trial; Treatment within 2 months with anti-VEGF agent in the fellow eye or anticipated need for further treatment during the study; Patients with any cancer diagnosis in remission for less than 5 years with the exception that patients with skin cancers, basal cell or squamous cell, treated exclusively or topical treatment will be allowed; Female patients who have not reached menopause, defined as cessation of menses for a minimum of 12 months with no perimenopausal symptoms; Patients who have significant wound healing during the trial; Patients with a history of vitrectomy in the study eye; patients with uncontrolled psoriasis, rheumatoid arthritis, osteoarthritis
Information: info@efei.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: BioCurrent Electrical Stimulation for the Treatment of Dry ARMD
ClinicalTrials.gov Identifier: NCT02699216
Sponsor: DuBois Vision Clinic
Purpose: To evaluate the treatment of Dry Macular Degeneration and the resulting change in vision with a very, very low current that is similar to what occurs in the body naturally.
Design: Randomized, Safety/Efficacy, Crossover Assignment, Double-Blind, Treatment
Number of Patients: 616
Inclusion Criteria: Best-corrected visual acuity can be no better than 20/40 and no worse than 20/200 for each enrolled eye; confirmed diagnosis of Dry MD; vision loss attributable to Dry MD.
Exclusion Criteria: Any retinal pathology other than Dry MD; evidence or history of wet MD; previous intravitreal injection; seizure disorders; dense cataract; eyelid pathology at the treatment sites.
Information: telephonescreener@outlook.com
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
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 randomised, double-masked, parallel group, multicentre 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 neovascularisation (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: Efficacy and Safety of RTH258 Versus Aflibercept
ClinicalTrials.gov Identifier: NCT02307682
Sponsor: Alcon Research
Purpose: The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT) injection at 2 dosage levels to aflibercept solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
Design: Randomized, Parallel Assignment, Double Masking, Treatment
Number of Patients: 1,600
Inclusion Criteria: Active CNV lesions secondary to AMD in the study eye; Intra and/or subretinal fluid affecting the central subfield of the study eye; BCVA between 78 and 23 letters, inclusive, in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
Exclusion Criteria: Any active intraocular or periocular infection or active intraocular inflammation in either eye; Fibrosis or geographic atrophy; Any approved or investigational treatment for neovascular AMD (other than vitamin supplements) in the study eye at any time; Any history or evidence of a concurrent intraocular condition in the study eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the course of the study to prevent or treat visual loss; Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks; History or evidence of surgery to the study eye, as specified in the protocol; Uncontrolled glaucoma in the study eye; aphakia and/or absence of the posterior capsule in the study eye; Use of corticosteroids, ocular and systemic, as specified in the protocol; Treatment with aflibercept (Eylea), bevacizumab (Avastin), ranibizumab (Lucentis), or pegaptanib (Macugen) in the nonstudy eye, as specified in the protocol; History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product; History of hypersensitivity to any component of the test article, control article, or ophthalmic dye, as assessed by the Investigator; Pregnant, lactating, or women of child-bearing potential, unless using effective methods of contraception during dosing of study treatment; Stroke or myocardial infarction in the 90 day period prior to enrollment; Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg; Participation in an investigational drug, biologic, or device study, as specified in the protocol.
Study: Episcleral Brachytherapy for the Treatment of Wet AMD (NEAMES)
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: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
ClinicalTrials.gov Identifier: NCT02867735
Sponsor: Novartis Pharmaceuticals
Purpose: To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO).
Design: Randomized, Parallel Assignment, Single Masking
Number of Patients: 28
Inclusion Criteria: Patients with macular edema with center involvement in at least one eye, including those with focal or diffuse DME, neovascular AMD, or RVO; The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63); Vital signs as specified within the protocol.
Exclusion Criteria: Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage; patients with type 1 or type 2 diabetes who have a hemoglobin A1C > or = 12% at screening; other ocular conditions as specified in the protocol; systemic conditions as specified in the protocol.
Information: 1-888-669-6682
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: EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection
ClinicalTrials.gov Identifier: NCT02689518
Sponsor: University of California, San Diego/Regeneron
Purpose: To evaluate individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration.
Design: Single Group, Open Label, Treatment
Number of Patients: 100
Inclusion Criteria: Naïve neovascular wet-age-related macular degeneration (has not received treatment before); age 50
Exclusion Criteria: Previous therapy in study eye for age-related macular degeneration or other retinal disease which may be used in the treatment of age-related macular degeneration; previous subfoveal focal laser photocoagulation involving the foveal center in the study eye; history of vitrectomy, submacular surgery, or other surgical intervention for age-related macular degeneration in the study eye; any concurrent intraocular condition in the study eye.
Information: cwen@ucsd.edu
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: Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME
ClinicalTrials.gov Identifier: NCT02571972
Sponsor: Wills Eye
Purpose: This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections in nonresponders with wet age-related macular degeneration.
Design: Single Group, No Masking, Treatment
Number of Patients: 15
Inclusion Criteria: Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina, volunteer patients age 18 years and older, healthy enough to participate in the study, willing and able to consent to participation in the study, diagnosis of wet age-related macular degeneration, 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, Injection of the same anti-VEGF agent for at least 2 visits prior to study enrollment, Fixed interval between at least 2 visits prior to study enrollment.
Exclusion Criteria: History of uveitis, any ophthalmic surgery within previous 6 months, including cataract extraction, any history of vitrectomy, history of any glaucoma drop usage or prior glaucoma surgery, systemic diuretic or corticosteroid usage, any contraindication (bradycardia, decompensated heart failure, or reactive airway disease) for topical use of a beta-blocker, Any history of sulfonamide allergy.
Information: research@midatlanticretina.com
Study: STAIRWAY: Study to Evaluate RO6867461 (RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration (nAMD)
ClinicalTrials.gov Identifier: NCT03038880
Sponsor: Hoffman-La Roche
Purpose: This is a Phase II, multicenter, randomized, active comparator-controlled, 52-week study to investigate the efficacy, safety and pharmacokinetics of RO6867461 (RG7716) administered with extended dosing regimens in treatment-naive participants with nAMD. Only one eye will be chosen as the study eye.
Design: Randomized, Parallel Assignment, Double-Blind, Treatment
Number of Patients: 75
Inclusion Criteria: Treatment-naive CNV secondary to AMD; subfoveal CNV or CNV lesion component; active CNV; BCVA letter score of 73 to 24 letters (inclusive).
Exclusion Criteria: CNV due to causes other than AMD; retinal pigment epithelial tear involving the macula; on fundus fluorescein angiography (FFA) subretinal hemorrhage, fibrosis or atrophy of >50% of the total lesion area and/or that involves the fovea; cataract surgery within 3 months of baseline assessments; uncontrolled blood pressure.
Information: global-roche-genentech-trials@roche.com
Study: DAWN: Dorzolamide-timolol in Combination With Antivascular 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: Study of DS-7080a for the Treatment of Neovascular AMD
ClinicalTrials.gov Identifier: NCT02530918
Sponsor: Daiichi Sankyo Inc.
Purpose: To test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration.
Design: Randomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 63
Inclusion Criteria: Active primary subfoveal CNV lesions secondary to AMD; CNV ≥50% of total lesion size in study eye; central sub-field thickness >315 µm on SD-OCT in the study eye.
Exclusion Criteria: Presence of RPEl tears or rips involving the macula in the study eye; history of any vitreous hemorrhage within 4 weeks prior to screening visit; the presence of causes of CNV other than AMD; prior vitrectomy.
Information: ssaigal@oraclinical.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: X-82 to Treat Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02348359
Sponsor: Tyrogenex
Purpose: To evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.
Design: Randomized, Safety/Efficacy, Single Group, Double-Blind, Treatment
Number of Patients: 132
Inclusion Criteria: Participants must have wet AMD which has been diagnosed and treated with anti-VEGF in one or both eyes for at least 1 year prior to joining the study and has required at least 3 prior injections of Eylea at intervals of not greater than 6 weeks for the past 3 injections in the eye that is selected to be the study eye; must have demonstrated the ability to achieve a dry macula in the study eye 14 days following an injection of Eylea at Screening Visit 1; Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 20 letters (20/400) or better in both eyes.
Exclusion Criteria: Previous vitrectomy to the study eye; choroidal neovascularization (CNV) due to causes other than AMD; proliferative diabetic retinopathy in either eye.
Information: denis@tyrogenex.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
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: Variable Interval Versus Set Interval Aflibercept for DME (EVADE)
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: TYBEE: Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
ClinicalTrials.gov Identifier: NCT03126786
Sponsor: Clearside Biomedical, Inc.
Purpose: The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.
Design: Randomized, Parallel Assignment, Quadruple Masking, Treatment
Number of Patients: 71
Inclusion Criteria: Clinical diagnosis of type 1 or type 2 DM; DME with central involvement (>300 µm in the central subfield on spectral-domain optical coherence tomography [SD-OCT], in the study eye); ETDRS BCVA score of
Exclusion Criteria: IOP>21 mmHg in the study eye at Visit 1 (Day -30 to -1) — subjects are not excluded if IOP is <22 mmHg in the study eye with no more than 1 IOP lowering medication; any previous treatment in the study eye with an ocular corticosteroid implant; has significant media opacity precluding evaluation of retina and vitreous in the study eye; history of glaucoma or optic nerve head change consistent with glaucoma damage; history of glaucoma surgery; history of clinically significant IOP elevation in response to corticosteroid treatment (“steroid responder”).
Information: Kathleen Billman: (678)894-0703, Kathleen.billman@clearsidebio.com; Nichole Wilkes: (678)254-2376, Nichole.wilkes@clearsidebio.com
Study: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
ClinicalTrials.gov Identifier: NCT02867735
Sponsor: Novartis Pharmaceuticals
Purpose: To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO).
Design: Randomized, Parallel Assignment, Single Masking
Number of Patients: 28
Inclusion Criteria: Patients with macular edema with center involvement in at least one eye, including those with focal or diffuse DME, neovascular AMD, or RVO; The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63); Vital signs as specified within the protocol.
Exclusion Criteria: Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage; patients with type 1 or type 2 diabetes who have a hemoglobin A1C > or = 12% at screening; other ocular conditions as specified in the protocol; systemic conditions as specified in the protocol.
Information: (888)669-6682
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: 30
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: Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME
ClinicalTrials.gov Identifier: NCT02571972
Sponsor: Wills Eye
Purpose: This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections in nonresponders with wet age-related macular degeneration.
Design: Single Group, No Masking, Treatment
Number of Patients: 15
Inclusion Criteria: Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina, volunteer patients age 18 years and older, healthy enough to participate in the study, willing and able to consent to participation in the study, diagnosis of wet age-related macular degeneration, 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, Injection of the same anti-VEGF agent for at least 2 visits prior to study enrollment, fixed interval between at least 2 visits prior to study enrollment.
Exclusion Criteria: History of uveitis, any ophthalmic surgery within previous 6 months, including cataract extraction, any history of vitrectomy, history of any glaucoma drop usage or prior glaucoma surgery, systemic diuretic or corticosteroid usage, any contraindication (bradycardia, decompensated heart failure, or reactive airway disease) for topical use of a beta-blocker, Any history of sulfonamide allergy.
Information: research@midatlanticretina.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: 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
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: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
ClinicalTrials.gov Identifier: NCT02867735
Sponsor: Novartis Pharmaceuticals
Purpose: To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO).
Design: Randomized, Parallel Assignment, Single Masking
Number of Patients: 28
Inclusion Criteria: Patients with macular edema with center involvement in at least one eye, including those with focal or diffuse DME, neovascular AMD, or RVO; The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63); Vital signs as specified within the protocol.
Exclusion Criteria: Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage; patients with type 1 or type 2 diabetes who have a hemoglobin A1C > or = 12% at screening; other ocular conditions as specified in the protocol; systemic conditions as specified in the protocol.
Information: (888)669-6682
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: TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion
ClinicalTrials.gov Identifier: NCT03093701
Sponsor: Taiwan Liposome Company
Purpose: Eligible subjects with macular edema will be enrolled to receive a single dose of the study drug, TLC399, with either of the 3 dose strengths by intravitreal route (IVT). Each of the 3 groups will include approximately 22 subjects. The subjects will be followed for visual acuity, safety, tolerability and retinal thickness assessment after the single IVT injection of the study drug on Day 1.
Design: Randomized, Parallel Assignment, Double-Blind, Treatment
Number of Patients: 66
Inclusion Criteria: Adults at least 18 years of age, have macular edema due to CRVO or BRVO, have best-corrected visual acuity (CVA) score of 20/40 to 20/400, have a mean central subfield thickness (CST) ≥350 um, be willing and able to comply with the study procedure and sign a written consent form, must agree to use a medically acceptable form of birth control.
Exclusion Criteria: Poorly controlled diabetes, history of significant intraocular pressure elevation to steroid treatment, history of ocular hypertension and glaucoma, cataract surgery in the study eye within 3 months, or intraocular surgery within 6 months prior to the screening visit, use of hemodilution for the treatment of RVO, use of IVT ranibizumab or bevacizumab in the study eye within 6 weeks prior to the screen visit, or IVT aflibercept within 8 weeks prior to the screening visit, IVT Ozurdex to the study eye within 6 months prior to the screening visit, prior use of Retisert or Iluvien, use of systemic steroids or heparin within 1 month prior to the screening visit.
Information: jenny_chen@tlcbio.com, juliet@tlcbio.com
Study: Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME
ClinicalTrials.gov Identifier: NCT02571972
Sponsor: Wills Eye
Purpose: This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections in nonresponders with wet age-related macular degeneration.
Design: Single Group, No Masking, Treatment
Number of Patients: 15
Inclusion Criteria: Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina, volunteer patients age 18 years and older, healthy enough to participate in the study, willing and able to consent to participation in the study, diagnosis of wet age-related macular degeneration, 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, Injection of the same anti-VEGF agent for at least 2 visits prior to study enrollment, Fixed interval between at least 2 visits prior to study enrollment.
Exclusion Criteria: History of uveitis, any ophthalmic surgery within previous 6 months, including cataract extraction, any history of vitrectomy, history of any glaucoma drop usage or prior glaucoma surgery, systemic diuretic or corticosteroid usage, any contraindication (bradycardia, decompensated heart failure, or reactive airway disease) for topical use of a beta-blocker, Any history of sulfonamide allergy.
Information: research@midatlanticretina.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
Study: ORION: Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion (Status = Unknown)
ClinicalTrials.gov Identifier: NCT01827722
Sponsor: Valley Retina Institute
Purpose: To assess the safety and effectiveness of treating CRVO-associated Macular Edema with a combination of 0.7 mg of Ozurdex and 0.5 mg Lucentis, given as separate injections into the eye.
Design: Safety/Efficacy, Randomized, Parallel Assignment, Single-Blind, Treatment
Number of Patients: 45
Inclusion Criteria: Adults greater than or equal to 18 years of age with foveal center involved macular edema secondary to CRVO diagnosed within 12 months before the screening visit (CRVO is defined as an eye with retinal hemorrhage or other biomicroscopic evidence of RVO [eg, telangiectatic capillary bed] and a dilated [or previously dilated] venous system in at least 3 quadrants of the retina drained by the affected vein; best corrected visual acuity (ETDRS) letter score of 73 to 24 inclusive (20/40 to 20/320) in the study eye at Screening and at Day 1.
Exclusion Criteria: History of vitreoretinal surgery in the study eye or anticipated within 12 months of Day 1; current bilateral manifestation of CRVO; decrease in VA due to causes other than CRVO in the study eye; prior episode of RVO in study eye; afferent pupillary defect, obvious and unequivocal.
Information: research@vritx.com, ysalinas@vritx.com
UVEITIS
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: A Phase 3 Study to Evaluate ADX-102 Ophthalmic Solution in Subjects With Noninfectious 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: Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis (EGP-437-006)
ClinicalTrials.gov Identifier: NCT02517619
Sponsor: Eyegate Pharmaceuticals, Inc.
Purpose: The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with noninfectious anterior segment uveitis.
Design: Randomized, Parallel Assignment, Quadruple Masking, Treatment
Number of Patients: 250
Inclusion Criteria: Age 12 to 85 years with a diagnosis of noninfectious anterior segment uveitis defined as an AC cell count of ≥11 cells; Receive, understand, and sign a copy of the written informed consent form; Be able to return for all study visits and willing to comply with all study-related instructions.
Information: lbrandano@eyegatepharma.com, cassang@eyegatepharma.com
Study: Efficacy and Safety of Filgotinib in Adults With Active Non-Infectious Uveitis (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: Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial (MERIT)
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: prpl@mail.cc.nih.gov
Study: Intravitreal Sirolimus as Therapeutic Approach to Uveitis (SAVE-2)
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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