Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
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)
- Diabetic Retinopathy
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- AbbVie
- Enrolment target
- 576
- Started
- 1 June 2026
- Main results due
- June 2028
- Study sites
- 34
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion) * Moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (early treatment diabetic retinopathy study-diabetic retinopathy severity scale \[DRSS\] level 47 or 53) for which panretinal photocoagulation (PRP) or anti- vascular endothelial growth factor (VEGF) can be safely deferred for at least 6 months after Screening Visit 1. * Best-corrected visual acuity (BCVA) in the study eye of \>= 69 Early treatment diabetic retinopathy study letters (approximate Snellen equivalent 20/40 or better) at Screening Visit 1. Systemic • Diabetic retinopathy (DR) secondary to diabetes mellitus Type 1 or 2 with a hemoglobin A1c (HbA1c)\< 12% within 60 days prior to Screening Visit 1. Exclusion Criteria: Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion) * Presence of active center involved-diabetic macular edema (CI-DME) in the study eye as determined by spectral domain optical coherence tomography (SD-OCT) evaluated by the central reading center (CRC), using the following threshold: Central retinal thickness (CRT) \>= 320 μm as measured by Heidelberg Spectralis SD-OCT (conversion to equivalent measurement is required and performed by the CRC if imaging is done with another SD-OCT instrument). * Active ocular inflammation including scleral inflammation (including episcleritis) or ocular/ periocular infection present in either eye at Screening Visit 1 or Screening Visit 2 * Neovascularization from a cause other than DR, per investigator * Evidence or documented history of panretinal photocoagulation (PRP) or retinal laser therapy * History of intravitreal therapy, including anti-VEGF and long- or short-acting steroid therapy, within the prior 6 months and documentation of more than 10 prior anti-VEGF or short acting steroid intravitreal injections within 36 months of Screening Visit 1 * Pregnant and breastfeeding individuals are excluded from this clinical study. Systemic * Initiation of intensive insulin treatment (pump or multiple daily injections) within the past 6 months or plans to do so within 52 weeks after Day 1 * Initiation of any treatment containing a GLP-1 receptor agonist within the 3 months prior to Screening Visit 1 or plans to do so within 52 weeks after Day 1 * Pregnant and breastfeeding individuals are excluded from this clinical study
What this study is about
In the sponsor’s own words, from the registry.
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 sites(34)
Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
Phoenix, Arizona, United States
Recruiting
Retina Macula Institute of Arizona /ID# 282881
Scottsdale, Arizona, United States
Recruiting
Barnet Dulaney Perkins Eye Center - Sun City /ID# 283000
Sun City, Arizona, United States
Recruiting
California Retina Consultants - Bakersfield /ID# 282990
Bakersfield, California, United States
Recruiting
Retina-Vitreous Associates Medical Group - Beverly Hills /ID# 282995
Beverly Hills, California, United States
Recruiting
The Retina Partners /ID# 274741
Encino, California, 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
Retina Consultants San Diego /ID# 274748
Poway, California, United States
Recruiting
West Coast Retinal Medical Group /ID# 283007
San Francisco, California, United States
Recruiting
Macula Retina Vitreous Center - Torrance /ID# 282878
Torrance, California, United States
Recruiting
Bay Area Retina Associates /ID# 275032
Walnut Creek, California, United States
Recruiting
Southwest Retina Research Center /ID# 276094
Durango, Colorado, United States
Recruiting
Colorado Retina Associates /ID# 283006
Lakewood, Colorado, United States
Recruiting
Advanced Vision Surgery Center /ID# 275017
Longmont, Colorado, United States
Recruiting
Florida Retina Consultants - Lakeland /ID# 275012
Lakeland, Florida, United States
Recruiting
Florida Retina Institute - Orlando /ID# 283034
Orlando, Florida, United States
Recruiting
Retina Speciality Institute /ID# 274996
Pensacola, Florida, United States
Recruiting
Southeast Retina Center /ID# 274739
Augusta, Georgia, United States
Recruiting
Illinois Retina Associates S.C /ID# 283048
Chicago, Illinois, United States
Recruiting
University Retina - Oak Forest /ID# 283021
Oak Forest, Illinois, United States
Recruiting
Springfield Clinic - First /ID# 283028
Springfield, Illinois, United States
Recruiting
Retina Associates - Lenexa /ID# 283004
Lenexa, Kansas, United States
Recruiting
Maine Eye Center - Marginal Way Campus /ID# 275039
Portland, Maine, 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 Center Of New Jersey /ID# 283088
Bloomfield, New Jersey, United States
Recruiting
Retina Associates Of Cleveland - Beachwood /ID# 275985
Beachwood, Ohio, United States
Recruiting
Charleston Neuroscience Institute - Charleston /ID# 275047
Charleston, South Carolina, United States
Recruiting
Austin Research Center for Retina /ID# 276101
Austin, Texas, United States
Recruiting
Star Retina /ID# 276513
Burleson, Texas, United States
Recruiting
Texas Retina Associates - Dallas /ID# 276117
Dallas, Texas, United States
Recruiting
Vistar Eye Center - Salem /ID# 282879
Salem, Virginia, United States
Recruiting
Emanuelli Research & Development Center /ID# 275378
Arecibo, Puerto Rico
Recruiting
Showing 34 of 34 sites. 34 of the 34 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07592273. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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