Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Public ClinicalTrials.gov record NCT05296447. 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 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05296447
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 3, 2022
- Primary completion
- May 31, 2031
- Completion
- May 31, 2031
- Last update posted
- Aug 4, 2026
2022 – 2031
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85014 | — |
| California Retina Consultants | Bakersfield | California | 93309 | — |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | — |
| Retinal Diagnostic Center | Los Angeles | California | 90017 | — |
| Northern California Retina Vitreous Associates Medical Group Inc | Mountain View | California | 94040 | — |
| California Eye Specialists Medical Group, Inc | Pasadena | California | 91107 | — |
| Retina Consultants San Diego | Poway | California | 92064 | — |
| California Retina Consultants CRC | Santa Barbara | California | 93103 | — |
| Southeast Retina Center, PC | Augusta | Georgia | 30909 | — |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | — |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | — |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | — |
| Sierra eye Associates | Reno | Nevada | 89502 | — |
| New Jersey Retina | Teaneck | New Jersey | 07666 | — |
| Vision Research Center Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | — |
| Charles Retina Institute, P.C | Germantown | Tennessee | 38138 | — |
| Austin Clinical Research | Austin | Texas | 78750 | — |
| Retina 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 NCT05296447, 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 Aug 4, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05296447 live on ClinicalTrials.gov.