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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
NotablePrimary endpoints: details revised at 2 of 5 entriesStudy sites: 31 to 33 · Eligibility criteria expanded, about 11 words · Secondary endpoints: details revised at 14 of 57 entriesShow 3 more changesShow less
Study sites: 31 to 33
Eligibility criteria expanded, about 11 words
Secondary endpoints: details revised at 14 of 57 entries
MinorStudy sites: 30 to 31v17
MinorTrial sites expanded: 27 → 30 locationsv16
MinorTrial sites expanded: 24 → 27 locationsv15
MinorStudy sites: 23 to 24v14
MinorTrial sites expanded: 18 → 23 locationsv13
MinorTrial sites expanded: 15 → 18 locationsv12
MinorStudy sites: 14 to 15v11
MinorStudy sites: 13 to 14v10
MinorStudy sites: 11 to 13v9
MinorTrial sites expanded: 8 → 11 locationsv8
MinorStudy sites: 7 to 8v7
MinorStudy sites: 6 to 7v6
MinorTrial sites expanded: 3 → 6 locationsStart date changed from estimate of May 20, 2026 to Jun 1, 2026v5Show 1 more changeShow less
Start date changed from estimate of May 20, 2026 to Jun 1, 2026
MinorRe-verified, no change to tracked fieldsv4
MinorStudy sites: 2 to 3v3
NotableRecruitment openedCompletion moved earlier from Feb 2036 to Jan 2036 · Start date: May 21, 2026 to May 20, 2026 · Site details revised at 2 of 2 sitesv2Show 3 more changesShow less
Completion moved earlier from Feb 2036 to Jan 2036
Start date: May 21, 2026 to May 20, 2026
Site details revised at 2 of 2 sites
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.