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NCT07592273 · ClinicalTrials.gov registry record · Phase 2
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
A Phase 2 study, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 576
- Enrollment target
NCT07592273 is a Phase 2 study that is actively recruiting participants, run by AbbVie. The registered enrollment target is 576 participants.
The verdict
NCT07592273, a Phase 2 study, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 576 participants
- Enrollment target
Study Summary
Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. This study will assess surabgene lomparvovec (sura-vec) as a potential one-time gene therapy administered in the suprachoroidal space (SCS) for the treatment of diabetic retinopathy (DR) and prevention of vision-threatening events (VTEs) in participants with non-proliferative DR (NPDR) without center-involved diabetic macular edema (CI-DME). This study will consist of 3 portions: a Phase 2b portion, a Phase 3 portion, and a bilateral treatment portion. Approximately 576 adult participants will be enrolled in the study across multiple sites in the United States and Puerto Rico. In the Phase 2b and Phase 3 portions, participants will be randomized to different groups to receive sura-vec and prophylactic steroids or sham and artificial tears in their study eye. If assigned to sham, participants will be given an opportunity to cross over and receive treatment with sura-vec. In the bilateral treatment portion, participants will be enrolled to receive sura-vec and prophylactic steroids in both eyes. In all 3 portions, follow-up in the study will continue through 5 years following administration of sura-vec in each eye. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
- DRUG Sham
- DRUG Topical Steroid
- DRUG Artificial Tears
- DRUG Surabgene Lomparvovec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 576 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2036-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07592273
The ClinicalTrials.gov registry entry for NCT07592273 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 576 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sham is the first listed.
NCT07592273 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07592273 about?
NCT07592273 is a clinical study titled "Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema". Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. This study will assess surabgene lompa...
What is the current status of trial NCT07592273?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 576 participants. The study started on 2026-06-01. Estimated completion is 2036-01.
What interventions are being tested in trial NCT07592273?
The interventions under investigation include: Sham (DRUG), Topical Steroid (DRUG), Artificial Tears (DRUG), Surabgene Lomparvovec (DRUG).
Who is sponsoring clinical trial NCT07592273?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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