Article

CLINICAL TRIAL UPDATE

CLINICAL TRIAL UPDATE

DRY AMD

Study: Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 in Treating Dry AMD

Sponsor: MacuCLEAR, Inc.

Purpose: To assess the efficacy, safety, and tolerability of MC-1101 for these patients

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 60

Inclusion Criteria: 20/80 or better ETDRS best-corrected visual acuity; early to intermediate nonexudative AMD

Exclusion Criteria: Past or current exudative AMD or central geographic atrophy in study eye; AMD Category 4 on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories; past or current retinal or choroidal vasculopathy in study eye

Information: pralston@macuclear.com

Study: SPECTRI/CHROMA: 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

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: BEACON: A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to AMD

Sponsor: Allergan

Purpose: To assess the safety and efficacy of the brimonidine intravitreal implant in patients with geographic atrophy due to AMD

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 300

Inclusion Criteria: Geographic atrophy due to age-related macular degeneration in the study eye; visual acuity better than or equal to 20/62 in the study eye and 20/200 in the fellow eye

Exclusion Criteria: Cataract surgery or LASIK in the study eye in the last 3 months; infections in either eye in the last 3 months

Information: clinicaltrials@allergan.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

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 one 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: klh7v@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

Number of Patients: 100

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: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 66

Inclusion Criteria: Participant 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: meg.gordon@nih.gov

Study: CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy

Sponsor: Alcon Research

Purpose: To evaluate the safety and efficacy of 12 (every 28 days) intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as compared to sham in subjects with geographic atrophy

Design: Randomized, Safety, Parallel Assignment, Single-blind

Number of Patients: 114

Inclusion Criteria: Geographic atrophy in both eyes

Exclusion Criteria: Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study; any contraindications or hypersensitivities to any component of the LFG316 or CLG561 solution; any contraindications to IVT injections; ocular surgery in either eye within 90 days of screening; uncontrolled ocular hypertension or glaucoma in the either eye

Information: alcon.medinfo@alcon.com

Study: FILLY: Study of of APL-2 Therapy in Patients Geographic Atrophy

Sponsor: Apellis Pharmaceuticals

Purpose: To assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of APL-2 in subjects with Geographic Atrophy associated with age-related macular degeneration

Design: Randomized, Safety/Efficacy, Single Group, Single-blind

Number of Patients: 240

Inclusion Criteria: BCVA of 20/320 (Snellen equivalent) or better using ETDRS charts; diagnosis of GA of the macula secondary to age-related macular degeneration, confirmed within 14 days prior to randomization by the central reading center (CRC) using Fundus Autofluorescence (FAF) images

Exclusion Criteria: Absence of hyperautofluorescence (ie none) or presence of focal pattern of hyperautofluorescence adjacent to the area of GA; GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy; spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm; any history or current evidence of exudative (“wet”) AMD including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere in the retina based on fluorescein angiogram as assessed by the CRC

Information: federico@apellis.com

Study: PORTRAY: Study to Evaluate Sub-retinal Transplantation of Retinal Pigmented Epithelial Cells in Patients With Dry AMD

Sponsor: Ocata Therapeutics

Purpose: To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection prophylaxis prior to and/or following transplant of MA09-hRPE cells

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 60

Inclusion Criteria: Geographic atrophy (GA) secondary to AMD with no evidence of prior to active choroidal neovascularization (CNV) in the study eye; BCVA in the study eye must be between 4 and 58 Early Treatment of Diabetic Retinopathy Study (EDTRS) letters (20/800 to 20/80; 0.025-0.25); subjects must be willing to take IMT and be willing to discontinue any medication that has a known strong interaction with tacrolimus or mycophenolate mofetil (MMF)

Exclusion Criteria: Macular atrophy due to causes other than AMD; other sight-threatening ocular disease; current or prior history of optic neuropathy, retinal dystrophy, retinitis pigmentosa, chorioretinitis, vasoocclusive disease, retinal vascular disease or retinal degenerative disease other than AMD; history of uveitis; history of allergic reaction to sulfa drugs

Information: research@midatlanticretina.com

Study: A 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, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 300

Inclusion Criteria: Diagnosis of Non-foveal GA secondary to dry AMD

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 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 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: Evaluation of Lipoic Acid as a Treatment for 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, Single Group, Open Label

Number of Patients: 15

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

DRY AMD

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

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

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 (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

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

Number of Patients: 255

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

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: RESCUE: Ranibizumab for Recalcitrant Wet AMD in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept

Sponsor: Northern California Retina Vitreous Associates/Genentech

Purpose: To determine the effectiveness of ranibizumab 0.5 mg or 1.0 mg in subjects who were previously treated with bevacizumab and subsequently switched to aflibercept

Design: Interventional, Nonrandomized, Efficacy, Parallel Assignment, Open Label

Number of Patients: 8

Inclusion Criteria: Best-corrected ETDRS VA between 20/25 to 20/320; total area of subretinal hemorrhage and/or fibrosis comprising less than 50% of lesion; any neovascular lesion type of ARMD having previously received at least 3 doses 1.25 mg of bevacizumab and/or ranibizumab (minimum 3 monthly injections) followed by 3 monthly doses of aflibercept 2.0 mg (with last injection being within 8 weeks) with evidence of recalcitrant ARMD, defined by at least one of the following: persistent subretinal fluid with or without intraretinal cystic edema on SD-OCT and/or leakage on fluorescein angiography

Exclusion Criteria: History of prior vitrectomy surgery; previous treatment with photodynamic therapy, radiation, or any other intravitreal drug delivery

Information: alcon.medinfo@alcon.com

Study: A Phase 3 Safety and Efficacy Study of Fovista (E10030) Intravitreous Administration in Combination With Lucentis Compared to Lucentis Monotherapy

Sponsor: Ophthotech Corp.

Purpose: To evaluate the safety and efficacy of intravitreal administration of Fovista administered in combination with Lucentis compared to Lucentis monotherapy in subjects with subfoveal choroidal neovascularization secondary to AMD

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 622

Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD with some classic component; presence of sub-retinal hyper-reflective material (SD-OCT)

Exclusion Criteria: Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals; any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids); any intraocular surgery or thermal laser within three (3) months of trial entry; any prior thermal laser in the macular region

Information: Karen.Lewis@ophthotech.com

Study: PREVENT: Prophylactic Ranibizumab for Exudative AMD

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 one eye (study eye); history of exudative AMD in one 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: Efficacy and Safety of RTH258 Versus Aflibercept

Sponsor: Alcon

Purpose: To compare RTH258 ophthalmic solution for intravitreal (IVT) injection at two dosage levels to aflibercept solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization secondary to AMD

Design: Randomized, Parallel Assignment, Double-blind

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

Information: alcon.medinfo@alcon.com

Study: X-82 to Treat AMD

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

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 Non-vitrectomized Eyes With Wet AMD

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, Pharmacokinetics, 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

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

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: Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to AMD

Sponsor: Neurotech Pharmaceuticals

Purpose: To compare NT-503-3 ECT to Eylea injected intravitreally every 8 weeks in the prevention of vision loss due to recurrent CNV secondary to AMD

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 170

Inclusion Criteria: Diagnosis of active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye; prior Intravitreal Anti-VEGF injections

Exclusion Criteria: Significant subretinal hemorrhage; significant scar and/or fibrosis; suspected polypoidal choroidopathy, or pigment epithelial tears or rips; inadequate response to anti-VEGF therapy

Information: c.johnson@neurotechusa.com

Study: Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular AMD

Sponsor: Ohr Pharmaceutical

Purpose: To evaluate anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 20

Inclusion Criteria: A diagnosis of choroidal neovascularization secondary to age-related macular degeneration (AMD) with choroidal neovascularization (CNV) comprising at least 50% of the total lesion area in the study eye; central retinal thickness ≥ 300 μm and presence of subretinal fluid or cystoid edema by OCT; BCVA of 20/40 to 20/320 by ETDRS Protocol

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; PED without associated subretinal fluid and/or cystic retinal changes; clinical evidence of diabetic retinopathy or DME

Information: 1501safety@ohrpharmaceutical.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

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 AMD

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

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

WET AMD

Study: LADDER: Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular AMD

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

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

Study: Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular AMD

Sponsor: Alcon/Novartis

Purpose: To evaluate the safety and tolerability of single ascending doses of LMG324 to determine the maximum tolerated dose (MTD) in neovascular age-related macular degeneration (nvAMD) subjects

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 106

Inclusion Criteria: Untreated or previously treated CNV lesion due to AMD; BCVA of approximately 20/200 Snellen or better in the non-study eye

Exclusion Criteria: Current vitreous hemorrhage or a history of rhegmatogenous retinal detachment; uncontrolled glaucoma; uncontrolled blood pressure; uncontrolled atrial fibrillation within 3 months of informed consent

Information: alcon.medinfo@alcon.com

Study: CDER: A Safety and Efficacy Study of Abicipar Pegol in Patients With Neovascular AMD

Sponsor: Allergan

Purpose: To study abicipar pegol in patients with neovascular AMD

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 900

Inclusion Criteria: 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: 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

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: Study of Intravitreal REGN2176-3 in Patients With Neovascular Age-related Macular Degeneration

Sponsor: Regeneron

Purpose: To explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in patients with neovascular age-related macular degeneration (AMD), compared to aflibercept monotherapy

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 500

Inclusion Criteria: Active subfoveal choroidal neovascularization secondary to AMD as evidenced by fluorescein angiography in the study eye, as determined by the reading center, including juxtafoveal lesions that affect the fovea; BCVA by ETDRS letter score of 73 to 24

Exclusion Criteria: Any prior treatment with anti-VEGF inhibitors in the study eye; any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors; dense fibrotic scar or atrophy in the study eye involving the center of the fovea; presence of retinal pigment epithelial tears or rips involving the macula in the study eye; prior vitrectomy in the study eye; any history of macular hole of stage 2 and above in the study eye; any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery; history of corneal transplant in the study eye; evidence of diabetic retinopathy or diabetic macular edema in either eye; positive serum human chorionic gonadotropin/urine pregnancy test at the screening or baseline visit

Information: clinicaltrials@regeneron.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

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: 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

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: 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

Number of Patients: 360

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 choridal 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: Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD

Sponsor: Raj K. Maturi, MD, PC

Purpose: To determine safety and efficacy of intravitreal injections of Sirolimus with adjunct EYLEA in subjects with exudative age-related macular degeneration (AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous intravitreal antiVEGF treatment

Design: Randomized, Parallel Assignment, Single-blind

Number of Patients: 20

Inclusion Criteria: BCVA 5 - 75 (20/800-20/30), inclusive, in study eye; if both eyes are eligible, the eye with the best potential visual improvement as determined by the investigator will be selected for treatment; presence of choroidal neovascularization secondary to AMD; at least 3 previous intravitreal anti-VEGF injections in the past 6 months

Exclusion Criteria: Decrease of greater than 150 microns in central subfield thickness as measured by OCT since the last intravitreal injection in the study eye; aphakia; history of pars plana vitrectomy in the study eye; history of major ophthalmic surgery in the study eye in the past 3 months and any ophthalmic surgery in the study eye within the past 30 days; history of significant ocular disease or condition other than exudative AMD that may confound results

Information: rmaturi@gmail.com

DIABETIC MACULAR EDEMA

Study: Phase II Combination Steroid and Anti-VEGF for Persistent DME

Sponsor: DRCRnet

Purpose: To assess whether the addition of steroid to an anti-VEGF treatment regimen in pseudophakic eyes has beneficial effect short-term in eyes with persistent DME and vision impairment despite previous anti-VEGF therapy, compared with anti-VEGF therapy alone

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 125

Inclusion Criteria: At least 6 injections of anti-VEGF drug within the prior 36 weeks; VA letter score in study eye ≤78 and ≥24 on clinical exam; definite retinal thickening due to DME involving the center of the macula

Exclusion Criteria: Condition where VA loss would not improve from resolution of macular edema; an ocular condition is present that, in the opinion of the investigator, might affect macular edema or alter VA during the course of the study; substantial posterior capsule opacity

Information: http://drcrnet.jaeb.org/ViewPage.aspx?PageName=Home

DIABETIC MACULAR EDEMA

Study: ROTATE: Ranibizumab For Persistent DME After Bevacizumab

Sponsor: Southeast Retina Center/Genentech

Purpose: To determine the safety and efficacy of intravitreally administered 0.3 mg ranibizumab in subjects with persistent DME after recent and frequent bevacizumab

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Open Label

Number of Patients: 30

Inclusion Criteria: Central-involved DME in study eye; definite retinal thickening due to DME involving the center of the macula

Exclusion Criteria: Allergy to ranibizumab; acute cardiovascular event requiring hospitalization within the past 3 months; systemic anti-VEGF or pro-VEGF treatment within 3 months

Information: dmarcus@southeastretina.com

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

Sponsor: Diabetic Retinopathy Clinical Research Network/Genentech

Purpose: To compare the percentage of eyes that have lost at least 5 letters of VA at 2 years compared with baseline mean VA in eyes with central-involved DME and good VA

Design: Randomized, Interventional, Safety/Efficacy, Parallel Assignment, Single-blind

Number of Patients: 702

Inclusion Criteria: Best corrected E-ETDRS VA letter score ≥ 79 at two consecutive visits within 1 to 28 days; on clinical exam, definite retinal thickening

Exclusion Criteria: Macular edema is due to a cause other than DME

Information: drcrnet@jaeb.org

Study: A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema

Sponsor: River Vision Development Corp.

Purpose: To evaluate the safety of teprotumumab in patients with DME

Design: Safety, Single Group, Open Label

Number of Patients: 10

Inclusion Criteria: Clinically significant DME of less than 12 months duration; non-PDR of moderate severity

Exclusion Criteria: Systemic anti-VEGF treatment within four months prior to enrollment; history of PRP within four months prior to enrollment

Information: kcgabriel2@verizon.net

Study: A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of Luminate (ALG-1001) as Compared to Avastin and Focal Laser Photocoagulation in the Treatment of DME

Sponsor: Allegro Ophthalmics

Purpose: To evaluate the safety and efficacy of Luminate compared to Avastin and focal laser in the treatment of DME

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 150

Inclusion Criteria: BCVA of 20/50 to 20/320 ETDRS equivalent in the study eye, with BCVA decrement primarily attributable to DME; treatment naïve; in the investigator’s opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA; IOP under control and study eye not receiving any IOP-lowering drops

Exclusion Criteria: Active PDR in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma; uncontrolled hypertension; focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment; a history of intravitreal anti-VEGF injection of any type in the study eye within the last 45 days prior to study enrollment

Information: (949) 940-8130

Study: DIME: Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema

Sponsor: California Retina 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

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 DME with documented incomplete resolution of central subfield thickening by SD-OCT

Exclusion Criteria: Evidence of vitreoretinal interface abnormality contributing to the macular edema; an eye that has no chance of improving in VA following resolution of macular edema

Information: sarahf@californiaretina.com

Study: ERASER: Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab

Sponsor: California Retina Consultants

Purpose: To evaluate the impact of ranibizumab on day-to-day visual function in patients with Diabetic Macular Edema

Design: Efficacy, Single Group, Open Label

Number of Patients: 60

Inclusion Criteria: Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy; central DME present on clinical examination or evidence indicating disease activity on spectral domain OCT

Exclusion Criteria: Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study; evidence of active neovascularization of the iris or retina

Information: crcjgiust@yahoo.com

DIABETIC MACULAR EDEMA

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: To study intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield

Design: Randomized, Efficacy, Parallel Assignment, Open Label

Number of Patients: 30

Inclusion Criteria: 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: ≥290μm in women and ≥305 μm in men in the central subfield; Heidelberg Spectralis: ≥305μm in women and ≥320 μm 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

Information: jbecerra@southcoastretina.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

Number of Patients: 30

Inclusion Criteria: Foveal-involving retinal edema secondary to DME or RVO based on investigator review of SDOCT; 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: Swap Two: Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab

Sponsor: Rishi Singh, MD, Cleveland Clinic Foundation/Regenerson

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

Number of Patients: 20

Inclusion Criteria: Foveal-involving retinal edema secondary to DME based on investigator review of clinical exam and SDOCT 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

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

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

DIABETIC MACULAR EDEMA

Study: Anti-VEGF Treatment for Prevention of Proliferative Diabetic Retinopathy/Diabetic Macular Edema

Sponsor: DRCRnet/Regeneron

Purpose: To 1) determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of proliferative diabetic retinopathy or center-involving diabetic macular edema in eyes at high risk for development of these complications and 2) compare long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of disease with those that are observed initially, and treated only if high-risk proliferative diabetic retinopathy or center-involving diabetic macular edema with vision loss develops

Design: Randomized, Parallel Assignment, Double-blind, Prevention

Number of Patients: 322

Inclusion Criteria: Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score ≥79 (approximate Snellen equivalent 20/25 or better); severe non-proliferative diabetic retinopathy (NPDR) (based on the 4:2:1 rule) evident on clinical examination and on 7-modified field or 4-wide field digital fundus photographs as judged by the investigator, confirmed by central Reading Center fundus photograph grading prior to randomization as ETDRS level 47B to 53E; absence 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); absence 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.

Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant; a condition that, in the opinion of the investigator, would preclude participation in the study (eg, unstable medical status including blood pressure, cardiovascular disease, and glycemic control); initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months; participation in an investigational trial that involved treatment within 30 days of randomization with any drug that has not received regulatory approval for the indication being studied

Information: http://drcrnet.jaeb.org/ViewPage.aspx?PageName=Home

Study: EVADE: Variable Interval Versus Set Interval Aflibercept for Diabetic Macular Edema

Sponsor: California Retina Consultants/Regeneron

Purpose: 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

Design: Randomized, Single Group, Open Label

Number of Patients: 50

Inclusion Criteria: Patients with diabetic macular edema involving the center of the macular in the study eye (CST must measure at least 350µm on Heidelberg spectral-domain optical coherence tomography, or 333µm on Cirrus spectral-domain optical coherence tomography); decrease in vision determined to be primarily due to diabetic macular edema in the study eye; best-corrected visual acuity ETDRS letter score 78 to 24 (20/32 to 20/320) in the study eye

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 90 days prior to baseline (not including prior intravitreal aflibercept injection); 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

Information: sarahf@californiaretina.com

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

Sponsor: Hoffman-La Roche

Purpose: To determine the safety and efficacy of RO6867461 in patients with center-involving diabetic macular edema

Design: Randomized, Parallel Assignment, Double-blind

Number of Patients: 150

Inclusion Criteria: Macular edema associated with diabetic retinopathy (DR); decreased visual activity (VA) attributable primarily to diabetic macular edema

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 diabetic macular edema; 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.rochegenentechtrials@roche.com