RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
139actual
Sites
25
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-11-20 | actual | When the study began enrolling |
| Primary completion | 2026-06-18 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2020-09-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Diabetic Retinopathy (DR)
- Center-Involved Diabetic Macular Edema (CI-DME)
Interventions
- Genetic: ABBV-RGX-314 Dose 1 — also filed as Genetic/ Combination Product
- Genetic: ABBV-RGX-314 Dose 2 — also filed as Genetic/ Combination Product
- Genetic: ABBV-RGX-314 Dose 3 — also filed as Genetic/ Combination Product
- Drug: Topical Steroid
- Genetic: ABBV-RGX-314 Dose 4 — also filed as Genetic/ Combination Product
- Biological: Aflibercept
Primary outcomes
what the primary-completion date above is the date OFPart 1: Proportion of participants achieving a 2-step or greater improvement in DR in the study eye per the ETDRS-DRSS on 4 widefield digital stereoscopic fundus photography at Week 48
measured At Week 48
Part 2: Mean change from baseline in Best Corrected Visual Acuity (BCVA) in the study eye at Week 54.
measured At Week 54
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