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NCT07592273PHASE2, PHASE3Recruiting

Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema

AbbVie

Start Date

6/1/2026

Completion Date

1/1/2036

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Surabgene Lomparvovec

DRUG

Sham

DRUG

Topical Steroid

DRUG

Artificial Tears

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Conditions

Diabetic Retinopathy

Locations

Retinal Consultants Of Arizona - Phoenix - North /ID# 283407

Phoenix, Arizona 85053

United States

Northern California Retina Vitreous Associates /ID# 282994

Mountain View, California 94040-4119

United States

California Eye Specialists Medical Group /ID# 274705

Pasadena, California 91107

United States

Retina Consultants San Diego /ID# 274748

Poway, California 92064

United States

Macula Retina Vitreous Center - Torrance /ID# 282878

Torrance, California 90503

United States

Southwest Retina Research Center /ID# 276094

Durango, Colorado 81303

United States

Florida Retina Consultants - Lakeland /ID# 275012

Lakeland, Florida 33805

United States

Florida Retina Institute - Orlando /ID# 283034

Orlando, Florida 32806

United States

University Retina - Oak Forest /ID# 283021

Oak Forest, Illinois 60452

United States

Springfield Clinic - First /ID# 283028

Springfield, Illinois 62702

United States

Mid Atlantic Retina Specialists - Hagerstown /ID# 274725

Hagerstown, Maryland 21740

United States

Sierra Eye Associates /ID# 274737

Reno, Nevada 89502

United States

Retina Associates Of Cleveland - Beachwood /ID# 275985

Beachwood, Ohio 44122

United States

Austin Research Center for Retina /ID# 276101

Austin, Texas 78705

United States

Star Retina /ID# 276513

Burleson, Texas 76028

United States

Texas Retina Associates - Dallas /ID# 276117

Dallas, Texas 75231

United States

Vistar Eye Center - Salem /ID# 282879

Salem, Virginia 24153

United States

Emanuelli Research & Development Center /ID# 275378

Arecibo, 00612

Puerto Rico