Enrolling Studies

Vector gene therapy for patients with DME.

Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME).

The primary efficacy objective for this study is to evaluate the non-inferiority in the efficacy of ranibizumab 100 mg/mL delivered via the PDS Q24W compared with intravitreal ranibizumab of 0.5 mg Q4W on the basis of the following endpoint measured in the study eye: *Change in best-corrected visual acuity (BCVA) score from baseline averaged over Weeks 60 and 64 as measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

A multicenter, randomized, controlled, prospective, adaptive Phase 3 clinical trial of repeated intravitreal injections of ADX-2191 versus standard-of-care for the prevention of proliferative vitreoretinopathy.

 A Phase 2, 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) (ALTITUDE).

A Phase Iii, Multicenter, Randomized Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Patients With Diabetic Retinopathy.  Study GR41675 is a multicenter, randomized, visual assessor−masked study in patients with DR without DME to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab 100 mg/mL delivered via the Port Delivery System every 36 weeks (Q36W) relative to the comparator arm.

The main purpose of this study is to evaluate the effect of ISIS 696844 on the rate of change of the area of GA secondary to AMD measured by fundus autofluorescence (FAF).

The purpose is to evaluate the safety and tolerability of subcutaneous (SC) injections of elamipretide administered with the elamipretide delivery system in subjects with age-related macular degeneration (AMD) with non-central geographic atrophy (GA).

A Phase 2/3 Multicenter, Randomized, Double-Masked, Parallel-group, Placebo-controlled study to Investigate the Safety, Pharmacokinetics, Tolerability, and Efficacy of ALK-001 in Geographic Atrophy Secondary to Age-related Macular Degeneration.

AAV8 vector gene therapy (suprachoroidal injection) for patients with Wet AMD.

Phase II Study assessing the efficacy and safety of intravitreal injections of RBM-007 monotherapy and RBM-007 in combination of Eylea Compared to Eylea monotherapy subjects.

This is a Phase 1/2a open-label, dose-escalation study to assess the safety and tolerability of single doses of CLS-AX administered suprachoroidally following at least 3 prior treatments (the last of which will be administered at the Screening visit) with an intravitreal (IVT) anti-VEGF agent in AMD subjects.

Please check out this article where Dr. Barakat is quoted talking about the OASIS Phase 1/2a Clinical Trial of CLS-AX

A Phase 2b Randomized, Double-Masked, Controlled Trial To Establish The Safety And Efficacy Of Zimura™ (Complement C5 Inhibitor) Compared to SHAM in Subjects with Autosomal Recessive Stargardt Disease.

A prospective, randomized, double-masked, active comparator controlled, multicenter, two-arm, phase 3 study to investigate the efficacy and safety of intravitreal KSI-301 compared with intravitreal aflibercept in treatment-naïve participants with visual impairment due to macular edema secondary to retinal vein occlusion.  KSI-301 is an antibody biopolymer conjugate that inhibits vascular endothelial growth factor (VEGF). It is designed to provide similar (non-inferior) improvements in visual acuity with an extended intraocular half-life and longer treatment intervals compared other anti-VEGF therapies including aflibercept.