Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Public ClinicalTrials.gov record NCT07592273. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07592273
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 576 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2026
- Primary completion
- May 31, 2028
- Completion
- Dec 31, 2035
- Last update posted
- Sep 2, 2026
2026 – 2036
United States locations
- U.S. sites
- 29
- U.S. states
- 15
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Consultants Of Arizona - Phoenix - North /ID# 283407 | Phoenix | Arizona | 85053 | Recruiting |
| Retina Macula Institute of Arizona /ID# 282881 | Scottsdale | Arizona | 85255-4134 | Recruiting |
| California Retina Consultants - Bakersfield /ID# 282990 | Bakersfield | California | 93309 | Recruiting |
| The Retina Partners /ID# 274741 | Encino | California | 91436 | Recruiting |
| Northern California Retina Vitreous Associates /ID# 282994 | Mountain View | California | 94040-4119 | Recruiting |
| California Eye Specialists Medical Group /ID# 274705 | Pasadena | California | 91107 | Recruiting |
| Retina Consultants San Diego /ID# 274748 | Poway | California | 92064 | Recruiting |
| West Coast Retinal Medical Group /ID# 283007 | San Francisco | California | 94109 | Recruiting |
| Macula Retina Vitreous Center - Torrance /ID# 282878 | Torrance | California | 90503 | Recruiting |
| Southwest Retina Research Center /ID# 276094 | Durango | Colorado | 81303 | Recruiting |
| Colorado Retina Associates /ID# 283006 | Lakewood | Colorado | 80228 | Recruiting |
| Florida Retina Consultants - Lakeland /ID# 275012 | Lakeland | Florida | 33805 | Recruiting |
| Florida Retina Institute - Orlando /ID# 283034 | Orlando | Florida | 32806 | Recruiting |
| Retina Speciality Institute /ID# 274996 | Pensacola | Florida | 32503 | Recruiting |
| Southeast Retina Center /ID# 274739 | Augusta | Georgia | 30909 | Recruiting |
| Illinois Retina Associates S.C /ID# 283048 | Chicago | Illinois | 60657 | Recruiting |
| University Retina - Oak Forest /ID# 283021 | Oak Forest | Illinois | 60452 | Recruiting |
| Springfield Clinic - First /ID# 283028 | Springfield | Illinois | 62702 | Recruiting |
| Retina Associates - Lenexa /ID# 283004 | Lenexa | Kansas | 66215 | Recruiting |
| Maine Eye Center - Marginal Way Campus /ID# 275039 | Portland | Maine | 04101 | Recruiting |
| Mid Atlantic Retina Specialists - Hagerstown /ID# 274725 | Hagerstown | Maryland | 21740 | Recruiting |
| Sierra Eye Associates /ID# 274737 | Reno | Nevada | 89502 | Recruiting |
| Retina Center Of New Jersey /ID# 283088 | Bloomfield | New Jersey | 07003 | Recruiting |
| Retina Associates Of Cleveland - Beachwood /ID# 275985 | Beachwood | Ohio | 44122 | Recruiting |
| Charleston Neuroscience Institute - Charleston /ID# 275047 | Charleston | South Carolina | 29414 | Recruiting |
| Austin Research Center for Retina /ID# 276101 | Austin | Texas | 78705 | Recruiting |
| Star Retina /ID# 276513 | Burleson | Texas | 76028 | Recruiting |
| Texas Retina Associates - Dallas /ID# 276117 | Dallas | Texas | 75231 | Recruiting |
| Vistar Eye Center - Salem /ID# 282879 | Salem | Virginia | 24153 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07592273, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07592273 live on ClinicalTrials.gov.