Actively Recruiting
Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
Led by Sierra Eye Associates · Updated on 2025-04-24
18
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
Sponsors
S
Sierra Eye Associates
Lead Sponsor
R
REGENXBIO Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
CONDITIONS
Official Title
Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 25 to 89 years
- Diagnosed with type I or type II diabetes mellitus with center involved diabetic macular edema and prior treatment
- HbA1c level 12% or less
- Best corrected visual acuity (BCVA) in the study eye between 78 and 25 ETDRS letters (~20/32 to 20/320) at screening
- Visual loss mainly due to center involved diabetic macular edema
- Show clinical response to aflibercept injection in the study eye
- Able to provide written informed consent
You will not qualify if you...
- Women of childbearing potential
- Neovascularization in the study eye caused by conditions other than diabetic retinopathy
- Optic nerve pallor observed in the study eye
- History of pan retinal photocoagulation in the study eye
- Other eye conditions in the study eye that may require surgery within 6 months or interfere with study procedures
- Presence of an implant in the study eye at screening (except intraocular lens)
- Any condition limiting vision improvement in the study eye as judged by the investigator
- Active or history of glaucoma, steroid response, or ocular hypertension
- Prior intravitreal steroid injection in the study eye within 6 months before screening
- Prior Ozurdex injection in the study eye within 12 months before screening
- Prior Iluvien injection in the study eye within 36 months before screening
- Diabetic macular edema diagnosed 7 or more years ago
- History of chronic renal failure needing dialysis or kidney transplant
- Participation in other gene therapy studies or investigational product use within 30 days or plans to use investigational products within 6 months after enrollment
- Other unspecified inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sierra Eye Associates
Reno, Nevada, United States, 89502
Actively Recruiting
Research Team
C
Clinical Research Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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