Clinical Trials
Clinical trials are a necessary part of the process of developing new approaches to treating retinal conditions and help us understand retinal diseases more thoroughly. The specific trials we are conducting change regularly, but are all focused on optimizing outcomes for patients with retinal diseases. There are many potential benefits to participating in a clinical trial, including helping to advance the field of retinal diseases which include the most common causes of blindness in the USA and most developed countries around the world. Each clinical study has specific criteria that participants must meet. If you’re interested in participating in a clinical trial, please ask your doctor.
Wet Age-Related Macular Degeneration
A randomized, single- masked, active- controlled phase 2 study of the safety, tolerability, and efficacy of repeated doses of high-dose aflibercept in patients with neovascular age-related macular degeneration
A 64-week, two-arm, randomized, double-masked, multicenter, phase IIIb study assessing the efficacy and safety of brolucizumab 6mg compared to aflibercept 2mg in a treat-to-control regimen in patients with neovascular age-related macular degeneration.
A Phase III randomized, double-masked, parallel group, multicenter study to compare the efficacy, safety, tolerability, pharmacokinetics and immunogenicity between SCD411 and Eylea in subjects with neovascular age-related macular degeneration
A two-part, Phase I study to investigate the safety, tolerability, and pharmacokinetics of RO7250284 following intravitreal administration of unmasked multiple ascending doses and masked sustained delivery from the port delivery system in patients with neovascular age-related macular degeneration
A randomized, double-masked, phase III study of ABP 938 efficacy and safety compared to Aflibercept in subjects with neovascular age-related macular degeneration.
A Phase II, Randomized, Dose-escalation, Ranibizumab-controlled study to evaluate the efficacy, safety, and tolerability of RGX-314 gene therapy delivered via one or two suprachoroidal space (SCS) Injections in participants with neovascular age-related macular degeneration (nAMD)
NCT not yet available – A Multi-Center, Non-Randomized, Open-Label, Administration in Patients with Neovascular Age-Related Macular Degeneration
A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration.
Safety and Effectiveness of ONS-5010 Compared to Lucentis in Subjects with Neovascular Age-related Macular Degeneration.
A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients with Neovascular Age-Related Macular Degeneration.
A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD.
A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD
A Phase I, Open-label, Multicenter, Dose-Escalating Study to Evaluate the Safety and Tolerability of KH631 Gene Therapy in Participants with Neovascular Age-related Macular Degeneration.
A Multicenter, Open-Label, Dose-Escalation Phase I Clinical Study and Randomized, Double-Masked, Controlled, Dose Expansion Phase 2 Clinical Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity, and Pharmacokinetics of SKG0106 Intraocular Solution in Patients with Neovascular Age-Related Macular Degeneration (nAMD).
Dry Age-related Macular Degeneration
A Phase III multicenter, randomized, double-masked, sham controlled clinical trial to assess the safety and efficacy of intravitreal administration of ZIMURA in patients with Geographic Atrophy secondary to Dry Age-Related Macular Degeneration
A Double-Masked, Randomized, Sham-controlled, Parallel group, Multi-Center Study to assess the safety and efficacy of photobiomodulation (PBM) in subjects with Dry Age-Related Macular Degeneration (AMD)
A Multicenter, Open-label, Multiple dose study in patients with Geographic Atrophy Secondary to Dry Age-related Macular Degeneration to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Repeat Intravitreal Injections of GEM103
A Phase II, Randomized, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRX, an Antisense Inhibitor of Complement Factor B, in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration
Longitudinal Observational Study of Non Exudative Age-Related Macular Degeneration Imaged with Swept Source Optical Coherence Tomography
A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Study of the Safety, Tolerability, and Evidence of Activity of Intravitreal Injection of RO7171009 in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration
A Study of Disease Progression in Genetically Defined Subjects with Geographic Atrophy Secondary to Age-Related Macular Degeneration
A Phase II Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects with Geographic Atrophy (GA) secondary to age-related macular degeneration
Safety, tolerability and pharmacokinetics of single rising intravitreal doses of BI 754132 in patients with geographic atrophy secondary to age-related macular degeneration (open label, non-randomized, uncontrolled)
A Multicenter, Prospective, Observational Study of the Progressionof Intermediate Age-Related Macular Degeneration.
Microcurrent Stimulation Therapy for Nonexudative Age-Related Macular Degeneration (I-SIGHT): A Multicenter, Randomized, Sham-Controlled, Feasibility Device Trial.
A Single and Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Treatment Effect of Intravitreal AVD-104 in Participants with Geographic Atrophy Secondary to Age-related Macular Degeneration.
A Prospective, Multicenter, Open-Label, Observational, Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration.
A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD).
A Phase 1/2 Study To Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration.
A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants with Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration.
A Phase 3, Randomized, Double-Masked, Placebo-Controlled clinical trial to evaluate the efficacy, safety, and Pharmacokinetics of Subcutaneous Injections of Elamipretide in Sibjects who have Dry Age-Related Macular Degeneration (Dry AMD)
Diabetic Macular Edema
A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator study of the efficacy, safety, and pharmacokinetics of the port delivery system with Ranibizumab in patients with Diabetic Macular edema
A Phase II, Multi-Center, Randomized, Double-Masked, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema (DME)
A Prospective, Randomized, Double-Masked, Active Comparator-controlled, Multi-center, Two-arm, Phase III Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept iin Participants with Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)
A Randomized, Double-Masked, Active-Controlled Phase 2/3 study of the Efficacy and Safety of High-Dose Aflibercept in patients with Diabetic Macular Edema
Prospective Randomized Comparative Trial for Combination Dexamethasone Implant with PRN anti-VEGF therapy to anti-VEGF therapy alone in treatment resistant Diabetic Macular Edema: Informing the Role for Imaging Biomarkers and Combination Therapy
Treat and extend versus fixed dosing with Farcimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial.
A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients with Diabetic Macular Edema.
Diabetic Retinopathy
A Multi-center, Randomized, Double-Masked, 40-week, parallel group, placebo-controlled proof of concept study to investigate the efficacy and safety of RO6868847 in individuals with Diabetes Mellitus Type 1 or Type 2 with treatment naïve Diabetic Retinopathy (DR)
A Phase III, Multicenter, Randomized study of the efficacy, safety, and pharmacokinetics of the port delivery system with Ranibizumab in patients with Diabetic Retinopathy
A First-in Human Trial to Study Safety and Tolerability of Single Rising Intravitreal doses (Open Label, Non-randomized, Uncontrolled) and in Addition the Early Biological Response of Multiple Rising intravitreal Doses (Single-masked, randomized, Sham-controlled) of BI 764524 in panretinal photocoagulation (PRP) Treated Proliferative Diabetic Retinopathy (PDR) patients with Diabetic Macular Ischemia (DMI)
A Phase II, Randomized, Dose-escalation, Observation-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered Via One or Two Suprachoroidal Space (SCS) Injections in Participants With Diabetic Retinopathy (DR) Without Center Involved-Diabetic Macular Edema (CI-DME)
A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening (Protocol AF)
A Prospective, Randomized, Double-masked, Sham-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)-GLOW2
Retinal Vein Occlusion
An Eighteen-Month, Two-Arm, Randomized, Double-Masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Macular Edema secondary to Branch Retinal Vein Occlusion
An Eighteen-Month, Two-Arm, Randomized, Double-Masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Macular Edema secondary to Central Retinal Vein Occlusion
A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase III Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in participants with Visual Impairment due to treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion
A Phase 1b, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Investigate the Biological Activity, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7200394 in Participants with Macular Edema Secondary to Central Retinal Vein Occlusion.
Telangiectasia
A Natural History Observation and Registry Study of Macular Telangiectasia Type 2 The MacTel Study
A Natural History Observation and Registry Study of Macular Telangiectasia Type 2- The Mactel Study.
Uveitis
A Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye
An Open-label, Multi-center, Randomized, Phase II Study of the Safety, and Bioactivity of Two Dose Regimens of Subcutaneous Injections of ACTH Gel in Patients With Non-infectious Uveitis
Macular Edema Ranibizumab Vs. Intravitreal Anti-Inflammatory Therapy
A Phase III multicenter randomized, parallel-treatment, comparative effectiveness trial comparing adalimumab to conventional (small molecule) immunosuppression for corticosteroid spring in the treatment of non-infectious, intermediate, posterior, and panuveitides.
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients with Uveitic Macular Edema.
Nevus/Melanoma
A Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation Phase (Open-label, Ascending Single and Repeat Dose) and a Randomized, Masked Dose Expansion Phase Designed to Evaluate the Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Radiation Retinopathy
The ARRT trial will assess the safety and efficacy of 2mg IAI for the treatment of radiation retinopathy, including maculopathy and optic neuropathy
PVR
A multi-center, randomized, controlled, adaptive Phase 3 clinical trial of repeated intravitreal injections of ADX-2191 versus standard-of-care for the prevention of proliferative vitreoretinopathy
Retinal Artery Occlusion
A Phase 2, Double-masked, Randomize, Sham-controlled, Multiple-dose Study of the Efficacy and Safety of Intravitreal KUS121 in the Treatment of Non-Arteritic Central Retinal Artery Occlusion (CRAO) -GION-
Stargardts
A Phase 1/2 Study To Assess the Safety and Efficacy of OCU410ST For Stargardt Disease
Inherited Retinal Disease Registry
Global Patient Registry of Inherited Retinal Diseases.
Epiretinal Membrane
Randomized Trial Comparing Immediate versus Deferred Surgery for Symptomatic Epiretinal Membranes.
Ocular Oncology
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma.