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
Location: See location...
Intervention Type: Biological, Genetic
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 89
Healthy Volunteers: f
View:
• 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
Locations
United States
Nevada
Sierra Eye Associates
RECRUITING
Reno
Contact Information
Primary
Clinical Research Study Coordinator
jvannavong@sierraeyeassociates.com
775-329-0286
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2027-12
Participants
Target number of participants: 18
Treatments
Experimental: RGX-314 Treatment Arm (Dose 1)
Genetic: RGX-314 Dose 1~\- AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
Experimental: Treatment Arm (Dose 2)
Genetic: RGX-314 Dose 2~-AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
Active_comparator: Aflibercept Treatment Arm
Biological: Aflibercept IVT~* Commercially available Active Comparator~* Other Names: Eylea
Related Therapeutic Areas
Sponsors
Leads: Sierra Eye Associates
Collaborators: REGENXBIO Inc.