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)
Public ClinicalTrials.gov record NCT04567550. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Controlled, Dose-escalation Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered Via a Single Suprachoroidal Space (SCS) Injections in Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)(ALTITUDE)
Study identification
- NCT ID
- NCT04567550
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- AbbVie
- Industry
- Enrollment
- 139 participants
Conditions and interventions
Interventions
- ABBV-RGX-314 Dose 1 Genetic
- ABBV-RGX-314 Dose 2 Genetic
- ABBV-RGX-314 Dose 3 Genetic
- ABBV-RGX-314 Dose 4 Genetic
- Aflibercept Biological
- Topical Steroid Drug
Genetic · Biological · Drug
Eligibility (public fields only)
- Age range
- 25 Years to 89 Years
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 19, 2020
- Primary completion
- May 31, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Sep 16, 2025
2020 – 2026
United States locations
- U.S. sites
- 25
- U.S. states
- 13
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85014 | — |
| Barnet Dulaney Perkins Eye Center | Phoenix | Arizona | 85016 | — |
| California Retina Consultants | Bakersfield | California | 93309 | — |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90017 | — |
| Retinal Diagnostic Center | Campbell | California | 95008 | — |
| Northern California Retina Vitreous Associates Medical Group, Inc. | Mountain View | California | 94040 | — |
| California Eye Specialists Medical Group, Inc | Pasadena | California | 91107 | — |
| Retinal Consultants San Diego | Poway | California | 92064 | — |
| California Retina Consultants | Santa Barbara | California | 93103 | — |
| Southeast Retina Center, PC | Augusta | Georgia | 30909 | — |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | — |
| Springfield Clinic | Springfield | Illinois | 62702 | — |
| Wilmer Eye Institute/Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | — |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | — |
| Sierra Eye Associates | Reno | Nevada | 89502 | — |
| NJ Retina | Teaneck | New Jersey | 07666 | — |
| Vision Research Center Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | — |
| Duke University Eye Center | Durham | North Carolina | 27705 | — |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | — |
| Charles Retina Institute, P.C. | Germantown | Tennessee | 38138 | — |
| Retina Research Institute of Texas, LLC | Abilene | Texas | 79606 | — |
| Austin Clinical Research, LLC | Austin | Texas | 78750 | — |
| Star Retina | Burleson | Texas | 76028 | — |
| Retinal Consultants of Texas | The Woodlands | Texas | 77384 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04567550, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 16, 2025 · Synced Apr 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04567550 live on ClinicalTrials.gov.