Study of Surabgene Lomparvovec Gene Therapy Injected in the Eye for Adults With Diabetic Retinopathy Without Macular Edema

What this Trial Is About

Diabetic Retinopathy DR is a common eye condition caused by diabetes that damages blood vessels in the retina, potentially leading to vision problems or blindness if untreated. This trial evaluates surabgene lomparvovec sura-vec, a one-time gene therapy injected into the suprachoroidal space SCS, for adults with non-proliferative DR NPDR without center-involved diabetic macular edema CI-DME. The study includes Phase 2b, Phase 3, and a bilateral treatment portion, enrolling about 576 adult participants in the United States and Puerto Rico. Participants are randomized to receive either a single SCS injection of sura-vec with prophylactic steroids or a sham injection with artificial tears in one eye during the Phase 2b and Phase 3 portions. Those assigned to sham may later cross over to receive sura-vec. In the bilateral treatment portion, participants receive sura-vec and steroids in both eyes. Follow-up for all participants continues for up to five years after treatment to monitor effects and safety. During the study, participants attend regular clinic visits for medical assessments including vision tests, blood tests, and safety monitoring. Researchers evaluate vision changes using the Diabetic Retinopathy Severity Scale DRSS, track vision-threatening events, and monitor for side effects such as ocular inflammation. Questionnaires are also completed to assess participant experience. The study aims to measure improvements in diabetic retinopathy severity and the occurrence of adverse events over time.

Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema