CLINICAL TRIAL UPDATE

DRY AMD

Study: Treatment of Advanced Dry Age Related Macular Degeneration with AAVCAGsCD59

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: 25

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 three 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 three months of enrollment or are known or likely candidate for intraocular surgery (including cataract surgery) in the study eye within one 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 three 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

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 three 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 five 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 twelve 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

Sponsor: Regenerative Patch Technologies, LLC

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 five 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 two or more topical agents to control intraocular pressure; history of glaucoma-filtering surgery; presence of moderate to severe non-proliferative 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

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 hyperautofluorescence 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 (ie, 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: A Phase 2/3 Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

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: 300

Inclusion Criteria: Diagnosis of non-foveal 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: Desiree.Beutelspacher@Ophthotech.com

Study: SPECTRI: A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to AMD

Sponsor: Hoffmann-La Roche

Purpose: To conduct a study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-Blind, Treatment

Number of Patients: 936

Inclusion Criteria: Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization in both eyes

Exclusion Criteria: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD; previous laser photocoagulation for CNV, DME, RVO, and proliferative diabetic retinopathy; previous intravitreal drug delivery

Information: global.rochegenentechtrials@roche.com

Study: TOGA: Clinical Study to Evaluate Treatment With ORACEA for Geographic Atrophy

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 non-study eye; clinical diagnosis of geographic atrophy secondary to non-exudative 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 non-study eye requiring any treatment within 12 months prior to Day 0

Information: pay2x@virginia.edu, aml7q@virginia.edu

Study: A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy

Sponsor: Genentech

Purpose: To investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in patients with geographic atrophy (GA) secondary to AMD

Design: Randomized, Safety/Efficacy, Parallel Assignment, Single-Blind, Treatment

Number of Patients: 96

Inclusion Criteria: Patients aged 60-89 years with well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization

Exclusion Criteria: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD; previous subfoveal focal laser photocoagulation; laser photocoagulation in the study eye; previous intravitreal drug administration; GA in either eye due to causes other than AMD

Information: global.rochegenentechtrials@roche.com

Study: Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With AMD

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: 40

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 (eg, ethambutol, chloroquine, or hydroxychloroquine); participant has a condition that would preclude participation in the study

Information: Katherine.hall2@nih.gov

Study: Alpha Lipoic Acid in Geographic Atrophy

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

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

Sponsor: Jeffrey S. Heier, MD/Regeneron

Purpose: To evaluate intravitreal aflibercept injection (IAI) versus 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 non-exudative age-related degeneration characterized by the presence of many intermediate sized drusen, 1 or more large drusen, and/or hyperpigmentary changes. Fellow (non-study) eye must have CNV lesion (ie, 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

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: 285

Inclusion Criteria: Confirmed diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 28 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

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 non-diabetic patients with age-related macular degeneration

Design: Randomized, Safety/Efficacy, Parallel Assignment, Single-Blind, Treatment

Number of Patients: 100

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: Carbidopa-levodopa in Neovascular AMD

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-levodpa

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 three 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

Sponsor: University of California, Los Angeles

Purpose: This study is utilizing a new, FDA approved, non-standard 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 (e.g. 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, i.e. 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

Sponsor: Allergan

Purpose: To study abicipar pegol in patients with neovascular AMD

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-Blind, Treatment

Number of Patients: 900

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 non-study 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

Sponsor: Regenxbio Inc.

Purpose: To test RGX-314’s ability to treat neovascular AMD.

Design: Nonrandomized, 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 (≤65 and ≥35 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: 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: RGX-314.ClinOps@regenxbio.com

Study: Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration

Sponsor: SciFluor Life Sciences

Purpose: To evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with Neovascular (wet) Age-related Macular Degeneration (AMD).

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-Blind, Treatment

Number of Patients: 44

Inclusion Criteria: Active subfoveal choroidal neovascularization due to Age-related Macular Degeneration (AMD) that meet the following criteria: total lesion ≤12 Macular Photocoagulation Study (MPS) disc areas; choroidal neovascularization (CNV) >50% of lesion area; intraretinal or subretinal fluid due to choroidal neovascularization (CNV) visible on optical coherence tomography (OCT); No atrophy or fibrosis involving the center of the fovea; best-corrected Visual Acuity (BCVA) of 0.3 to 1.2 Early Treatment Diabetic Retinopathy Study (ETDRS; Logarithmic minimum angle of resolution [logMAR]) in the study eye, with BCVA decrement primarily attributable to neovascular age-related macular degeneration (AMD); treatment naive (ie, no previous anti-vascular endothelial growth factor [VEGF] treatment in the study eye) or previously treated study eye.

Exclusion Criteria: Fellow eye visual acuity (VA) worse than 1.3 Early Treatment Diabetic Retinopathy Study (ETDRS), Logarithmic minimum angle of resolution (logMAR) (ie, 35 letters equivalent); choroidal neovascularization (CNV) in the study eye secondary to other causes (eg, pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, posterior uveitis, or multifocal choroiditis); previous macular laser photocoagulation or ocular photodynamic therapy in the study eye; media opacities or abnormalities that would preclude visualization of the retina; other retinal pathologies that would interfere with vision.

Information: clinicaltrials@scifluor.com

Study: Proton Radiation Therapy for Macular Degeneration

Sponsor: University of Florida

Purpose: To determine if proton radiation therapy can provide effective and safe treatment for subfoveal neovascularization membrane.

Design: Safety, Single Group, Open Label, Treatment

Number of Patients: 10

Inclusion Criteria: Patients with subfoveal neovascular membranes identified on fluorescein angiography; visual acuity (best corrected vision) 20/200 or worse in affected eye; patient must be 50 years of age or older at time of consent; patients must have had prior treatment for macular degeneration with Avastin (bevacizumab) or Lucentis (ranibizumab).

Exclusion Criteria: History of diabetes.

Information: (877) 686-6009

Study: MAKO: Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD

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 > 300 um; best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopahty Study [ETDRS] chart).

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: Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD

Sponsor: Allergan

Purpose: Evaluate the safety and characterize the systemic pharmacokinetics (PK) of free and vascular endothelial growth factor (VEGF)-bound abicipar following single and multiple intravitreal injections of abicipar pegol in treatment-naïve patients with neovascular age-related macular degeneration (AMD).

Design: Randomized, Parallel Assignment, Open Label, Treatment

Number of Patients: 30

Inclusion Criteria: Presence of active subfoveal and/or juxtafovela choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Exclusion Criteria: History of or active periocular, ocular, or intraocular infection; previous use of verteporfin photodynamic therapy (PDT) or any ocular anti-angiogenic therapy (eg, aflibercept, bevacizumab, ranibizumab, pegaptanib), approved or investigational, for the treatment of neovascular AMD or previous therapeutic radiation in the region; prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD; macular hemorrhage that involves the center of fovea in the study eye; any prior or current systemic or ocular treatment (including surgery) for neovascular AMD in the study eye; treatment with ocular corticosteroid injections or implants within 6 months in the study eye; history or evidence of eye surgery: Pars plana vitrectomy, Submacular surgery or other surgical interventions for AMD, Incisional glaucoma surgery or Cataract or refractive surgery within the last 3 months; AMD in the non-study eye that requires anti-VEGF treatment.

Information: IR-CTRegistration@allergan.com

Study: Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD

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

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)

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

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 two 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 two 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 one 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 one year of enrollment; anterior segment laser surgery (laser trabeculoplasty) performed within one year of enrollment; glaucoma tube-shunt surgery; previous history of corneal transplant in the study or non-study 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(e.g. 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

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 non-responders 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 two visits prior to study enrollment, Fixed interval between at least two 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)

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

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: ONYX: Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection

Sponsor: Regeneron

Purpose: To compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection.

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-Blind, Treatment

Number of Patients: 365

Inclusion Criteria: Men or women ≥50 years of age with active subfoveal choroidal neovascularization secondary to age-related macular degeneration, including juxtafoveal lesions that affect the fovea as evidenced by fluorescein angiography in the study eye as assessed by a central reading center; best-corrected visual acuity by ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye.

Exclusion Criteria: Evidence of choroidal neovascularization due to any cause other than age-related macular degeneration in either eye; prior intravitreal injection of anti-VEGF in the study eye; evidence of diabetic macular edema or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients.

Information: clinicaltrials@regeneron.com

Study: Study of DS-7080a for the Treatment of Neovascular AMD

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: 45

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: A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-Related Macular Degeneration

Sponsor: Santen Inc.

Purpose: To evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration.

Design: Nonrandomized, Safety/Efficacy, Single Group, Open Label, Treatment

Number of Patients: 12

Inclusion Criteria: Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration; prior treatment in the study eye with any intravitreal anti-VEGF medication; at least one lesion in the study eye that meets minimal pathology criteria.

Exclusion Criteria: Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1; uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye.

Information: clinicaltrials@santeninc.com

Study: PREVENT: Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration

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

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 three prior injections of Eylea at intervals of not greater than 6 weeks for the past three 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: DRAW: A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Nonvitrectomized Eyes With Wet Age-Related Macular Degeneration

Sponsor: University of Nebraska/Regeneron

Purpose: To study the way that aflibercept injection behaves in the eye and in the body of patients with wet macular degeneration, in patients who have had previous vitreous removal surgery.

Design: Nonrandomized, Single Group, Open Label

Number of Patients: 15

Inclusion Criteria: Active neovascular AMD, with no history of treatment in the study eye; patients with non-vitrectomized eyes; patients with vitrectomized eyes; phakic and pseudophakic eyes are allowed in the study; willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures.

Exclusion Criteria: Presence of other retinal vascular diseases (diabetic retinopathy, vein occlusion) that could affect the VEGF levels within the eye; known hypersensitivity to aflibercept; autoimmune disease of the anterior segment or posterior chamber including chronic keratoconjunctivitis sicca, uveitis, iritis/scleritis, blepharitis of either eye; infectious conjunctivitis, keratitis, or endophthalmitis of either eye.

Information: lisa.greer@UNMC.edu, kristi.miller@UNMC.edu

Study: AVENUE: A Proof-of-Concept Study of RG7716 in Participants With Choroidal Neovascularization (CNV) Secondary to AMD

Sponsor: Hoffman-La Roche

Purpose: To evaluate the safety, tolerability, pharmacokinetics, and efficacy of RG7716 in participants with subfoveal CNV.

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-Blind, Treatment

Number of Patients: 271

Inclusion Criteria: Subfoveal CNV lesions of all types, secondary to AMD; active CNV.

Exclusion Criteria: CNV due to causes other than AMD; subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area; cataract surgery within 3 months of baseline.

Information: global.rochegenentechtrials@roche.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

Sponsor: Genentech

Purpose: To evaluate the efficacy and the safety of three 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, Double-Blind, Treatment

Number of Patients: 220

Inclusion Criteria: Newly diagnosed with wet AMD within 6 months of screening visit; patient must have received at least 2 ranibizumab injections within approximately 2 months prior to the screening visit; patient may have received up to 6 ITV anti-VEGF injections prior to the screening visit; demonstrated response to prior standard of care.

Exclusion Criteria: Study eye treatment with ITV bevacizumab within 5 months prior to the randomization visit, or with ITV aflibercept within 3 months 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: Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3 mg Lucentis

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 four 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

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: non-proliferative 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 (e.g., 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 (e.g., 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 (e.g., thioridazine [Mellaril], chloropromazine [Thorazine]) or supplemental niacin ≥3 grams/day; use of systemic steroids, NSAIDS (non-steroidal 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 (e.g., 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

Sponsor: Valeant Pharmaceuticals International

Design: Single Group, Open Label

Number of Patients : 125

Information: denise.raimondo@valeant.com

Study: PERMEATE: Peripheral and Macular Retinal Vascular Perfusion and Leakage in DME and RVO

Sponsor: Justis Ehlers/Regeneron

Purpose: To evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion.

Design: Safety/Efficacy, Single Group, Open Label, Treatment

Number of Patients: 31

Inclusion Criteria: Foveal-involving retinal edema secondary to DME or RVO based on investigator review of SD-OCT; ETDRS BCVA of 20/25 to 20/400 in the study eye.

Exclusion Criteria: Any prior or concomitant therapy with another investigational agent to treat DME or RVO in the study eye; prior panretinal photocoagulation in the study eye; prior intravitreal anti-VEGF therapy in the study eye; prior focal/grid laser photocoagulation.

Information: reesej3@ccf.org

Study: SwapTwo: Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab

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

Study: Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Diabetic Macular Edema

Sponsor: SciFluor Life Sciences

Purpose: To evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with diabetic macular edema.

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-Blind, Treatment

Number of Patients: 44

Inclusion Criteria: Retinal thickening secondary to type 1 or type 2 diabetes mellitus with Diabetic Macular Edema (DME) defined as central subfield thickness ≥325 microns (µm) on spectral domain OCT; best-corrected Visual Acuity (BCVA) of 0.3 to 1.2 Early Treatment Diabetic Retinopathy Study (ETDRS; Logarithmic minimum angle of resolution [logMAR]) in the study eye, with BCVA decrement primarily attributable to Diabetic Macular Edema (DME); treatment naïve (ie, no previous anti-vascular endothelial growth factor [VEGF] treatment in the study eye).

Exclusion Criteria: Active proliferative diabetic retinopathy (PDR) in the study eye, such as neovascularization of the optic disc (NVD), neovascularization elsewhere (NVE), vitreous hemorrhage, or neovascular glaucoma; previous panretinal photocoagulation (PRP) in study eye or the need for panretinal photocoagulation (PRP) within 2 months from the time of study enrollment, based on the Investigator’s opinion; previous focal laser photocoagulation within the foveal avascular zone; uncontrolled hypertension defined as systolic >180 millimeter of mercury (mmHg) or >160 mmHg on 2 consecutive measurements (during the same visit) or diastolic >100 mmHg on optimal medical regimen; screening glycated hemoglobin (HbA1c) blood test >12.0%; focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within 90 days (3 months) prior to study enrollment.

Information: clinicaltrials@scifluor.com

Study: HULK: Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema

Sponsor: Clearside Biomedical, Inc.

Purpose: To demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus.

Design: Nonrandomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment

Number of Patients: 20

Inclusion Criteria: DME with central involvement in the study eye; ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye.

Exclusion Criteria: Intraocular pressure ≥22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye; history of any previous ophthalmic surgeries in the study eye within 90 days of screening; subjects previously treated for DME cannot have been treated in the study eye with an intravitreal injection of anti-VEGF or periocular corticosteroids within 90 days prior to screening (Previous TX arm only); subjects previously treated for DME cannot have been treated in the study eye with intraocular corticosteroids within 6 months prior to screening (Previous TX arm only).

Information: kathleen.billman@clearsidebio.com, nichole.wilkes@clearsidebio.com

Study: Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs. Aflibercept in Patients With Diabetic Macular Edema

Sponsor: Arshad Khanani, MD, Sierra Eye Associates/Genentech

Purpose: To compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME.

Design: Randomized, Parallel Assignment, Single-Blind, Treatment

Number of Patients: 100

Inclusion Criteria: Exam and OCT confirming diabetic macular edema; visual acuity of 20/400 or better; no history of post injection pain or inflammation in the past.

Exclusion Criteria: History of endophthalmitis in either eye; current inflammation in either eye; uncontrolled or symptomatic dry eye syndrome; intravitreal injection less than 3 months ago; history of anterior or posterior uveitis; history of post injection pain with prior treatments; recent thromboembolic event (<3 months).

Information: arshad.khanani@gmail.com

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

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: A Phase 2 Study of RO6867461 in Participants With Center-Involving Diabetic Macular Edema (CI-DME) (BOULEVARD)

Sponsor: Hoffman-La Roche

Purpose: This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 28-week study in participants with CI-DME. Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. Participants will be randomized into each arm group (1:1:1) and total duration of the study will be approximately 32 weeks.

Design: Randomized, Parallel Assignment, Double-Blind, Treatment

Number of Patients: 226

Inclusion Criteria: Macular edema associated with diabetic retinopathy (DR), decreased visual activity (VA) attributable primarily to DME, diagnosis of diabetes mellitus (DM).

Exclusion Criteria: proliferative diabetic retinopathy (PDR), cataract surgery within 3 months of Baseline, or any other previous intraocular surgery, uncontrolled glaucoma, current or history of ocular disease in the study eye other than DME, major illness or major surgical procedure within 1 month prior to Day 1, uncontrolled blood pressure, glycosylated hemoglobin (HbA1c) greater than (>) 10 percent (%) at screening, untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to Day 1.

Information: global-roche-genentech-trials@gene.com

Study: Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME

Sponsor: Wills Eye

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 two visits prior to study enrollment, fixed interval between at least two visits prior to study enrollment.

Information: research@midatlanticretina.com

Study: Protocol V: Treatment for CI-DME in Eyes With Very Good VA Study

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 two 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 two 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. a) 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: Phase II Combination Steroid and Anti-VEGF for Persistent DME

Sponsor: Jaeb Center for Health Research

Purpose: To assess the short-term effects of combination steroid+anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with that of continued anti-VEGF therapy alone in eyes with persistent central-involved DME and visual acuity impairment despite previous anti-VEGF treatment.

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-Blind, Treatment

Number of Patients: 125

Inclusion Criteria: At least 3 injections of anti-VEGF drug (ranibizumab, bevacizumab, or aflibercept) within the prior 20 weeks; visual acuity letter score in study eye ≤78 and ≥24 (approximate Snellen equivalent 20/32 to 20/320); on clinical exam, definite retinal thickening due to DME involving the center of the macula; OCT CSF thickness, within 8 days of enrollment: i) On Zeiss Cirrus ≥290 microns in women; ≥305 in men ii) On Heidelberg Spectralis: ≥305 microns in women; ≥320 in men.

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 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 (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, non-retinal condition, etc.); 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

Sponsor: Jaeb Center for Health Research

Purpose: To determine the efficacy and safety of intravitreous aflibercept injections versus 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

Sponsor: Allergan/California Retinal Consultants

Purpose: To compare the effectiveness of using a dexamethasone steroid implant versus 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 six 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: Continuation of Previous Study to Gather More Data on Effect of Macugen on the Corneal Endothelium

Sponsor: Valeant Pharmaceuticals International

Design: Single Group, Open Label

Number of Patients : 125

Information: denise.raimondo@valeant.com

Study: TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion

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 three dose strengths by intravitreal route (IVT). Each of the three 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

Sponsor: Wills Eye

Design: Single Group, No Masking, Treatment

Number of Patients: 15

Information: research@midatlanticretina.com

Study: SAPPHIRE: Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

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, Double-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 ≥5 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; intraocular pressure >22 mmHg or uncontrolled glaucoma in study eye; any uncontrolled systemic disease that, in the opinion of the investigator, would preclude participation in the study; any evidence of neovascularization in the study eye.

Information: kathleen.billman@clearsidebio.com, nichole.wilkes@clearsidebio.com

Study: Minocycline to Treat Branch Retinal Vein Occlusion

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: chenfa@nei.nih.gov, cukrasc@mail.nih.gov

Study: Minocycline to Treat Central Retinal Vein Occlusion

Sponsor: National Eye Institute (NEI)

Purpose: To test the safety and effectiveness of minocycline as a treatment for central retinal vein occlusion (CRVO).

Design: Randomized; Parallel Assignment; Double-Blind, Treatment

Number of Patients: 20

Inclusion Criteria: Foveal center-involved macular edema secondary to a CRVO, 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: Macular edema considered to be due to a cause other than CRVO, history of recurrent RVO, RVO present for >18 months, brisk afferent pupillary defect present in the study eye, ocular condition present such that visual acuity would not improve from resolution of ME or that might affect macular edema or alter visual acuity during the study, substantial cataract likely to be decreasing visual acuity by 3 lines or more, panretinal or sectoral scatter photocoagulation (PRP) within 4 months prior to study entry, pars plana vitrectomy within 6 months prior to study entry, major ocular surgery within 3 months prior to study entry, yttrium aluminum garnet capsulotomy performed within 2 months prior to study entry, treatment <3 months prior to study entry of intravitreal or periocular steroid injections, intravitreal anti-VEGF treatment <28 days prior to study entry.

Information: chenfa@nei.nih.gov, cukrasc@mail.nih.gov

Study: Open Label Study to Assess the Efficacy and Safety of AKB-9778 in Subjects With Macular Edema Due to RVO

Sponsor: Aerpio

Purpose: To assess the efficacy and safety of subcutaneous 15mg AKB-9778 administered twice daily for 84 days in subjects with macular edema due to RVO.

Design: Safety/Efficacy, Single Group, Open Label, Treatment

Number of Patients: 20

Inclusion Criteria: Definite retinal thickening due to RVO involving the central macula based on investigator’s clinical evaluation and demonstrated by sdOCT; mean central subfield thickness of at least 300 µm by sdOCT with presence of intraretinal fluid; ETDRS BCVA letter score ≤76 and ≥24; decrease in vision determined to be primarily the result of macular edema due to RVO and not due to other causes.

Exclusion Criteria: Macular edema is considered to be due to a cause other than RVO; any other ocular disease that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), retinal inflammatory, infectious disease, or primary open-angle glaucoma; high myopia (-8 diopter or more correction).

Information: jbonfrisco@aerpio.com, mbrigell@aerpio.com

Study: ORION: Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion

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

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CLINICAL TRIAL UPDATE

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RETINAL VEIN OCCLUSION

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Retinal Physician

CLINICAL TRIAL UPDATE

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WET AMD

RETINAL VEIN OCCLUSION

Recommendations

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