Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema (NCT07592273)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Retinal Consultants Of Arizona - Phoenix - North /ID# 283407 — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (27 Sites)
Showing the first 25 of 27 sites.
- Retinal Consultants Of Arizona - Phoenix - North /ID# 283407 — Phoenix, Arizona
- Retina Macula Institute of Arizona /ID# 282881 — Scottsdale, Arizona
- California Retina Consultants - Bakersfield /ID# 282990 — Bakersfield, California
- The Retina Partners /ID# 274741 — Encino, California
- Northern California Retina Vitreous Associates /ID# 282994 — Mountain View, California
- California Eye Specialists Medical Group /ID# 274705 — Pasadena, California
- Retina Consultants San Diego /ID# 274748 — Poway, California
- Macula Retina Vitreous Center - Torrance /ID# 282878 — Torrance, California
- Southwest Retina Research Center /ID# 276094 — Durango, Colorado
- Florida Retina Consultants - Lakeland /ID# 275012 — Lakeland, Florida
- Florida Retina Institute - Orlando /ID# 283034 — Orlando, Florida
- Retina Speciality Institute /ID# 274996 — Pensacola, Florida
- Southeast Retina Center /ID# 274739 — Augusta, Georgia
- University Retina - Oak Forest /ID# 283021 — Oak Forest, Illinois
- Springfield Clinic - First /ID# 283028 — Springfield, Illinois
- Retina Associates - Lenexa /ID# 283004 — Lenexa, Kansas
- Maine Eye Center - Marginal Way Campus /ID# 275039 — Portland, Maine
- Mid Atlantic Retina Specialists - Hagerstown /ID# 274725 — Hagerstown, Maryland
- Sierra Eye Associates /ID# 274737 — Reno, Nevada
- Retina Center Of New Jersey /ID# 283088 — Bloomfield, New Jersey
- Retina Associates Of Cleveland - Beachwood /ID# 275985 — Beachwood, Ohio
- Charleston Neuroscience Institute - Charleston /ID# 275047 — Charleston, South Carolina
- Austin Research Center for Retina /ID# 276101 — Austin, Texas
- Star Retina /ID# 276513 — Burleson, Texas
- Texas Retina Associates - Dallas /ID# 276117 — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy — Phoenix, Arizona
- Implementation of Teleophthalmology in Urban Health Systems Study — Madison, Wisconsin
Explore by condition: All Diabetic Retinopathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.