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

Part of paid clinical trials in Mountain View, California.

Sponsor
AbbVie
Study ID
NCT07592273
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surabgene Lomparvovec — DRUG
    Solution Injection
  • Sham — DRUG
    needleless injection without fluid
  • Topical Steroid — DRUG
    Topical Drops
  • Artificial Tears — DRUG
    Topical Drops

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jan 31, 2036

Study Design

Enrollment
576 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2b: Surabgene Lomparvovec + Steroid-Regimen A
    Participants will receive a single Suprachoroidal space (SCS) injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen A.
  • Experimental: Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B
    Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B.
  • Placebo Comparator: Phase 2b: Sham + Artificial Tears -Regimen A
    Participants will receive a single injection of sham+ artificial tears -Regimen A.
  • Placebo Comparator: Phase 2b: Sham + Artificial Tears -Regimen B
    Participants will receive a single injection of Sham+ artificial tears -Regimen B.
  • Experimental: Phase 3: Surabgene Lomparvovec + Steroid
    Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
  • Placebo Comparator: Phase 3: Sham + Artificial Tears
    Participants will receive a single injection of Sham + artificial tears.
  • Experimental: Bilateral: B1-Surabgene Lomparvovec + Steroid
    Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye.
  • Experimental: Bilateral: B2-Surabgene Lomparvovec + Steroid
    Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye.

Primary Outcome Measure

Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye [ Time Frame: At Week 52 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Northern California Retina Vitreous Associates /ID# 282994Mountain ViewCalifornia94040-4119-
University Retina - Oak Forest /ID# 283021Oak ForestIllinois60452-
Austin Research Center for Retina /ID# 276101AustinTexas78705-

Find similar trials in Mountain View, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Northern California Retina Vitreous Associates· Mountain View, CAUniversity Retina - Oak Forest· Oak Forest, ILAustin Research Center for Retina· Austin, TX

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