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.
