Clinical Trials

Current Trials

Age-related Eye Disease Study (AREDS2)

10-Year Follow-on Study

Description: Provide additional data regarding the incidence of advanced AMD, cataract surgery and lung cancer on approximately 1,200 AREDS2 study participants

ALCON RTH258-C001

A Two-Year, Randomized, Double-Masked, Multicenter, Three-Arm Study Comparing the Efficacy and Safety of RTH258 versus Aflibercept in Subjects with Neovascular Age-related Macular Degeneration

Description: To demonstrate that RTH258 is not inferior to aflibercept with respect to the change in BCVA from baseline in patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration. Treatment arms: RTH258 3 mg, RTH258 6 mg and Aflibercept.

ARIS – AMD Ryan Initiative Study

Description: To assess rate of change in drusen volume and progression rates to large drusen, and associate these morphologic changes with psychophysical changes, including visual acuity and dark adaptation.

DRCR

Diabetic Retinopathy Clinical Research Network

Protocol T: A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema

Description: To compare the efficacy and safety of intravitreal aflibercept, intravitreal bevacizumab and intravitreal ranibizumab when given to treat center-involved DME in eyes.

Protocol V: Treatment for Central-Involved Diabetic Macular Edema in Eyes with Very Good Visual Acuity

Description: To compare the safety and efficacy of prompt focal/grid photocoagulation + deferred intravitreal anti-VEGF, observation + deferred intravitreal anti-VEGF, and prompt intravitreal anti-VEGF in eyes with central-involved DME and good visual acuity 20/25 or better.

Protocol W: Treatment for patients with severe NPDR, determined by Reading Center.

Description: Patient are treated with Eylea versus sham (observation) to determine if early treatment will slow the progression to PDR. Vision 20/25 or better. 4 year study

Protocol AA: Peripheral Diabetic Retinopathy Lesions on Ultrawide-field Fundus Images and Risk of DR Worsening over Time

Description: To assess whether evaluation of the retinal far periphery on ultrawide-field images improves the ability to assess DR and predict rates of DR worsening over time as compared with evaluation only of the area within the 7 standard ETDRS fields.

Protocol AB: Intravitreous Anti-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage from Proliferative Diabetic Retinopathy

Description: To evaluate and compare visual acuity outcomes over the course of the study of a prompt vitrectomy + PRP regimen and an intravitreous aflibercept regimen in eyes with VH from PDR for which intervention is deemed necessary

Protocol AD: Diabetic Retinopathy Outcomes in a Randomized Trial of Pemafibrate vs. Placebo

Description: To assess whether treatment with pemafibrate (0.2 mg orally BID) compared with placebo reduces the hazard rate of diabetic retinopathy worsening in adults with type 2 diabetes and diabetic retinopathy without neovascularization in at least one eye who are participating in the parent PROMINENT trial.

FILLY-POT

Description: Patients with Geographic Atrophy determined by Reading Center. Randomized to one of 4 arms. Study drug Monthly; Study drug EOM; Sham Monthly; Sham EOM. 12 month study.

SCORE2

Standard Care vs. Corticosteroid for Retinal Vein Occlusion 2 (Not enrolling)

Description: A randomized trial designed to test whether bevacizumab is non-inferior to aflibercept for the treatment of macular edema due to central retinal vein occlusion (CRVO). Treatment arms: intravitreal aflibercept(2mg) every 4 weeks or intravitreal bevacizumab (1.25mg) every 4 weeks.

YD312-01-P2 (YD Global Life Science Company)

Multi-center, Randomized, Double-Blind, Dose-Finding, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of YD312 Tablet in Patients with Diabetic Macular Edema

Description: To evaluate the efficacy of YD312 to improve visual acuity in patients with diabetic macular edema (DME) compared to placebo and determine optimal dose of phase 2b study.

Derby (Apellis)

A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Description: To determine if intravitreally injected APL-2 reduces the progression of GA compared to sham-injections in patients with GA secondary to AMD.

Past Trials

Home Vision Monitoring in AREDS2 for progression to Neovascular AMD Using the ForeseeHome Device

Description: To assess home vision monitoring using the ForeseeHome Device vs. Amsler grid in patients participating in AREDS2

APGS – AMD Phenotype and Genotype Study
ALLERGAN CEDAR

150998-005 Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-Related Macular Degeneration

Description: To assess the safety and efficacy of abicipar compared with ranibizumab in patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration. Treatment arms: 2mg abicipar 8 weeks, 2mg abicipar 12 weeks and ranibizumab.

AREDS2, Age-Related Eye Disease Study

Foreseehome: Home Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the Foreseehome Device APGS – AMD Phenotype and Genotype Study

ALLERGAN CEDAR

150998-005 Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-Related Macular Degeneration

Description: To assess the safety and efficacy of abicipar compared with ranibizumab in patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration. Treatment arms: 2mg abicipar 8 weeks, 2mg abicipar 12 weeks and ranibizumab.

AREDS2, Age-Related Eye Disease Study

Randomized Trial of Lutein, Zeaxanthin, and Long-Chain Omega-3 Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration

CATT

Comparison of Age-Related Macular Degeneration Treatment Trials

DRCR

Diabetic Retinopathy Clinical Research Network

Protocol S: Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab with Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Description: To determine if visual acuity outcomes at 2 years in eyes with PDR that receive anti-VEGF therapy with deferred PRP are non-inferior to those in eyes that received standard prompt PRP therapy.

Protocol U: Short-term Evaluation of Combination Corticosteroid + Anti-VEGF Treatment for Persistent Central-Involved Diabetic Macular Edema Following Anti-VEGF Therapy

Description: 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 done in eyes with persistent center-involved DME and decreased visual acuity despite previous anti-VEGF treatment.

GENENTECH (BOULEVARD)

Description: DME determined by Reading Center. Randomized to one of 3 arms. Lucentis q4weeks; Study drug (1.5mg) q4weeks; Study drug (6mg) q4weeks. Vision 20/40-20/320. 7 month study

GENENTECH GX29455

A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy

Description: The GX29455 Phase II is a controlled study of the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks or every 4 weeks for 24 weeks to CFI profile biomarker-positive patients with GA secondary to age-related macular degeneration (AMD). Treatment arms: lampalizumab every 2 weeks, lampalizumab every 4 weeks and sham injection.

Novartis SPP100A2244 Study

A randomized, double-masked, placebo-controlled, add-on study to assess the efficacy of oral aliskiren 300mg once daily for diabetic macular edema

iDEAL Study

A Randomized Multi-center, Phase 2 Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCO-007 as Monotherapy or in Combination with Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic macular edema with Involvement of the Foveal Center

Ohr 002

Phase 2 study of the efficacy and safety of Squalamine Lactate Ophthalmic Solution 0.2% twice daily in subjects with neovascular age-related macular degeneration

Ohr 003

Topical Squalamine In The Treatment Of Retinal Neovascularization From Proliferative Diabetic Retinopathy.

OHR

Description: Randomized to study drug (drops) or placebo. Patients will receive Lucentis Monthly for 1 year then PRN in year 2. Will use drops BID throughout the study. Vision 20/40-20/320. 2 year study

ORBIT

Ocriplasmin Research to Better Inform Treatment. (Not enrolling)

MERCK ALZHEIMER STUDY

OHR 1501

Phase 2 study of safety, functional and anatomical effect of Squalamine Lactate Ophthalmic Solution 0.2% administered twice daily in subjects with neovascular age-related macular degeneration

Description: The study will assess the safety of Squalamine Lactate Ophthalmic Solution 0.2% administered twice daily by subjects in combination with monthly intravitreal injections of Lucentis or Eylea.

Novartis

A Multi-center, randomized, sham-controlled, repeat-dose study to assess the safety-tolerability, serum pharmokinetics, and efficacy of intravitreal LFG316 in patients with neovascular age-related macular degeneration.

PEACHTREE

Uveitis study. Patients with non-infectious uveitis and macular edema. Randomized to triamcinolone vs sham suprachoroidal injections at Day 0 and Week 12. Vision 20/40-20/800. 6 month study

Post Treatment Foresee Home

Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular AMD

POSURDEX

A 6-Month, Single-Masked, Multicenter, Randomized, Controlled Study to Assess the Safety and Efficacy of 700ug Dexamethasone Posterior Segment Delivery System Applicator System as Adjunctive Therapy to Lucentis Alone in the Treatment of Patients with Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.

REGENERON

Description: Study drug (2 different doses) versus Eylea. Patients receive 3 doses then re-randomized based upon findings to possible different arm. Vision 20/40-20/320. 32 week study.

Xcovery

A Phase 1/2 Open-label, Dose Escalation Clinical Trial to Evaluate the Safety and Preliminary Biologic Activity/Efficacy of the VEGFR/PDGFR Inhibitor X-82 Administered Per Os in Subjects with Neovascular Age-related Macular Degeneration

XCOVERY 201

A Randomized, Double-Masked, Placebo-Controlled, Dose-Finding, Non-Inferiority Study of X-82 plus prn Eylea compared to prn Eylea monotherapy in neovascular AMD

Description: To evaluate the safety and efficacy of X-82 at three doses versus placebo in combination with intravitreal injection of Eylea prn for patients with wet age-related macular degeneration (AMD). Treatment arms: X-82 50mg, 100mg, or 200 mg plus Eylea prn versus placebo plus Eylea prn.

SIRIUS

Allergan SIRIUS Study 211745-001

SCORE

Standard Care vs. Corticosteroid for Retinal Vein Occlusion

VERTACLE

Multi-Center Randomized, Phase II/III Clinical Trial to Study the Effects of Preservative Free Triamcinolone Acetonide as an Adjunct to Photodynamic Therapy in Participants with Neovascular Age-Related Macular Degeneration

AREDS

Age-Related Eye Disease Study

EOP 1023

A Phase IV, open label, multi-center trial of maintenance intravitreal injections of Macugen (pegaptanib sodium) given every 6 weeks for 48 weeks in subjects with subfoveal neovascular Age-Related Macular Degeneration (AMD) initially treated with modality resulting in maculopathy improvement.