NCT05296447Enrolling by invitationPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy With and Without Center Involved-Diabetic Macular Edema
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR with and without center involved-diabetic macular edema (CI-DME) in which they received suprachoroidal space (SCS) administration of ABBV-RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for a total of 5 years post-ABBV-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following ABBV-RGX-314 administration in the parent study.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 16 Mar 2022
- Start date
- 4 Apr 2022
- Primary completion date
- Jun 2031
- Lead sponsor
- AbbVie
- Diseases
- Diabetic eye disease
- NCT number
- NCT05296447
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 4 Apr 2022 to the primary completion date, Jun 2031
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- Must provide written, signed informed consent for this study
- Must have been enrolled in a previous clinical study of ABBV-RGX-314 for the treatment of DR with or without CI-DME and must have received an SCS injection of ABBV-RGX-314 in that study
- Must be willing and able to comply with all study procedures
Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vision Research Center Eye Associates of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Southeast Retina Center, PC Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Austin Clinical Research Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Retina-Vitreous Associates Medical Group Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Ophthalmic Consultants of Boston Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Charles Retina Institute, P.C Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Cumberland Valley Retina Consultants Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Retinal Diagnostic Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Northern California Retina Vitreous Associates Medical Group INC. Coordinator of this site? Confirm its status | Mountain View | United States | Unknown status |
| University Retina and Macula Associates, PC Coordinator of this site? Confirm its status | Oak Forest | United States | Unknown status |
| California Eye Specialists Medical Group, Inc. Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Mid Atlantic Retina Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Retinal Research Institute, LLC Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Retina Consultants San Diego Coordinator of this site? Confirm its status | Poway | United States | Unknown status |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| California Retina Consultants CRC Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| New Jersey Retina Coordinator of this site? Confirm its status | Teaneck | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.