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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Sponsor: AbbVie
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.
Official title: An Operationally Seamless Phase 2b/3, Multicenter, Randomized, Masked, Sham-controlled Study to Evaluate the Efficacy and Safety of Surabgene Lomparvovec (Sura-vec) Delivered Via Suprachoroidal Space (SCS) Injection Targeting Subjects With Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema (CI-DME) (NAAVIGATE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
576
Start Date
2026-06-01
Completion Date
2036-01
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Surabgene Lomparvovec
Solution Injection
Sham
needleless injection without fluid
Topical Steroid
Topical Drops
Artificial Tears
Topical Drops
Locations (37)
Barnet Dulaney Perkins Eye Center - Mesa /ID# 283000
Mesa, Arizona, United States
Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
Phoenix, Arizona, United States
Retina Macula Institute of Arizona /ID# 282881
Scottsdale, Arizona, United States
California Retina Consultants - Bakersfield /ID# 282990
Bakersfield, California, United States
Retina-Vitreous Associates Medical Group - Beverly Hills /ID# 282995
Beverly Hills, California, United States
The Retina Partners /ID# 274741
Encino, California, United States
Northern California Retina Vitreous Associates /ID# 282994
Mountain View, California, United States
California Eye Specialists Medical Group /ID# 274705
Pasadena, California, United States
Retina Consultants San Diego /ID# 274748
Poway, California, United States
West Coast Retinal Medical Group /ID# 283007
San Francisco, California, United States
Macula Retina Vitreous Center - Torrance /ID# 282878
Torrance, California, United States
Bay Area Retina Associates /ID# 275032
Walnut Creek, California, United States
Southwest Retina Research Center /ID# 276094
Durango, Colorado, United States
Colorado Retina Associates /ID# 283006
Lakewood, Colorado, United States
Advanced Vision Surgery Center /ID# 275017
Longmont, Colorado, United States
Florida Retina Consultants - Lakeland /ID# 275012
Lakeland, Florida, United States
Florida Retina Institute - Orlando /ID# 283034
Orlando, Florida, United States
Retina Speciality Institute /ID# 274996
Pensacola, Florida, United States
Southeast Retina Center /ID# 274739
Augusta, Georgia, United States
Illinois Retina Associates S.C /ID# 283048
Chicago, Illinois, United States
University Retina - Oak Forest /ID# 283021
Oak Forest, Illinois, United States
Springfield Clinic - First /ID# 283028
Springfield, Illinois, United States
Retina Associates - Lenexa /ID# 283004
Lenexa, Kansas, United States
Maine Eye Center - Marginal Way Campus /ID# 275039
Portland, Maine, United States
Mid Atlantic Retina Specialists - Hagerstown /ID# 274725
Hagerstown, Maryland, United States
Sierra Eye Associates /ID# 274737
Reno, Nevada, United States
Retina Center Of New Jersey /ID# 283088
Bloomfield, New Jersey, United States
Retina Associates Of Cleveland - Beachwood /ID# 275985
Beachwood, Ohio, United States
Retina Northwest /ID# 283232
Portland, Oregon, United States
Charleston Neuroscience Institute - Charleston /ID# 275047
Charleston, South Carolina, United States
Austin Research Center for Retina /ID# 276101
Austin, Texas, United States
Retina and Vitreous of Texas /ID# 283051
Bellaire, Texas, United States
Star Retina /ID# 276513
Burleson, Texas, United States
Texas Retina Associates - Dallas /ID# 276117
Dallas, Texas, United States
Wagner Macula & Retina Center - Norfolk /ID# 275021
Norfolk, Virginia, United States
Vistar Eye Center - Salem /ID# 282879
Salem, Virginia, United States
Emanuelli Research & Development Center /ID# 275378
Arecibo, Puerto Rico