Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Start Date
6/1/2026
Completion Date
1/1/2036
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Surabgene Lomparvovec
Sham
Topical Steroid
Artificial Tears
Conditions
Locations
Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
Phoenix, Arizona 85053
United States
Northern California Retina Vitreous Associates /ID# 282994
Mountain View, California 94040-4119
United States
California Eye Specialists Medical Group /ID# 274705
Pasadena, California 91107
United States
Retina Consultants San Diego /ID# 274748
Poway, California 92064
United States
Macula Retina Vitreous Center - Torrance /ID# 282878
Torrance, California 90503
United States
Southwest Retina Research Center /ID# 276094
Durango, Colorado 81303
United States
Florida Retina Consultants - Lakeland /ID# 275012
Lakeland, Florida 33805
United States
Florida Retina Institute - Orlando /ID# 283034
Orlando, Florida 32806
United States
University Retina - Oak Forest /ID# 283021
Oak Forest, Illinois 60452
United States
Springfield Clinic - First /ID# 283028
Springfield, Illinois 62702
United States
Mid Atlantic Retina Specialists - Hagerstown /ID# 274725
Hagerstown, Maryland 21740
United States
Sierra Eye Associates /ID# 274737
Reno, Nevada 89502
United States
Retina Associates Of Cleveland - Beachwood /ID# 275985
Beachwood, Ohio 44122
United States
Austin Research Center for Retina /ID# 276101
Austin, Texas 78705
United States
Star Retina /ID# 276513
Burleson, Texas 76028
United States
Texas Retina Associates - Dallas /ID# 276117
Dallas, Texas 75231
United States
Vistar Eye Center - Salem /ID# 282879
Salem, Virginia 24153
United States
Emanuelli Research & Development Center /ID# 275378
Arecibo, 00612
Puerto Rico