Condition: Diabetic Retinopathy · Sponsor: AbbVie
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. …
This description comes directly from the study's public registry record.
ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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| Retinal Consultants Of Arizona - Phoenix - North /ID# 283407 | Phoenix, Arizona, United States | Recruiting |
| Northern California Retina Vitreous Associates /ID# 282994 | Mountain View, California, United States | Recruiting |
| California Eye Specialists Medical Group /ID# 274705 | Pasadena, California, United States | Recruiting |
| Macula Retina Vitreous Center - Torrance /ID# 282878 | Torrance, California, United States | Recruiting |
| Southwest Retina Research Center /ID# 276094 | Durango, Colorado, United States | Recruiting |
| Florida Retina Consultants - Lakeland /ID# 275012 | Lakeland, Florida, United States | Recruiting |
| University Retina - Oak Forest /ID# 283021 | Oak Forest, Illinois, United States | Recruiting |
| Mid Atlantic Retina Specialists - Hagerstown /ID# 274725 | Hagerstown, Maryland, United States | Recruiting |
| Sierra Eye Associates /ID# 274737 | Reno, Nevada, United States | Recruiting |
| Retina Associates Of Cleveland - Beachwood /ID# 275985 | Beachwood, Ohio, United States | Recruiting |
| Austin Research Center for Retina /ID# 276101 | Austin, Texas, United States | Recruiting |
| Star Retina /ID# 276513 | Burleson, Texas, United States | Recruiting |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07592273