A Randomized, Open Label, Controlled, Phase 2 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 AAV Gene Therapy Administered Via Subretinal Delivery in Participants With Center Involved Diabetic Macular Edema
Sierra Eye Associates
Summary
Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
Description
This Phase 2 trial is an open label, randomized, active controlled, dose-ranging trial to allow for preliminary safety and efficacy data on subretinal (SR) delivery of RGX-314 in participants with CI - DME
Eligibility
- Age range
- 25–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Type I or Type II diabetes mellitus with center involving diabetic macular edema with previous treatment * HbA1c ≤12% * BCVA in study eye 78 to 25 ETDRS letters (\~20/32 to 20/320) at screening * Decreased visual acuity attributable primarily due to CI - DME * Demonstrate clinical response to aflibercept injection in the study eye * Provide written informed consent Exclusion Criteria: * Women of childbearing potential * Neovascularization in the study eye from a cause other than DR * Evidence in the study eye of optic nerve pallor on clinical examination * History of p…
Interventions
- GeneticRGX-314 Dose 1
AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
- GeneticRGX-314 Dose 2
AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
- BiologicalAflibercept (2.0 mg)
Commercially available Active Comparator
Location
- Sierra Eye AssociatesReno, Nevada