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
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)
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
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)
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
Telangiectasia
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.
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
