NCT06942520

Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Sierra Eye Associates · Academic / Other
• Sex: All
• Age: 25 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)

Detailed 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

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
GENETIC	RGX-314 Dose 1	AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
GENETIC	RGX-314 Dose 2	AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
BIOLOGICAL	Aflibercept (2.0 mg)	Commercially available Active Comparator

Timeline

• Start date: 2025-03-18
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study