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Surabgene Lomparvovec for Diabetic Retinopathy

This study is testing surabgene lomparvovec (sura-vec), a potential one-time gene therapy, for adults with diabetic retinopathy (DR). DR is an eye condition caused by diabetes that can damage vision. The therapy is given as an injection in the suprachoroidal space (SCS) of the eye. Researchers want to see if surabgene lomparvovec can treat DR and prevent serious vision problems in people who have moderately severe or severe nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME). Success in this study means seeing a significant improvement in the severity of diabetic retinopathy after 52 weeks. The study plans to enroll 576 participants, but its current status is unclear.

Study design
This interventional study is structured in three parts: a Phase 2b, a Phase 3, and a bilateral treatment portion, involving up to 576 participants. It compares surabgene lomparvovec to a sham injection (a needleless injection without fluid), along with topical steroid and artificial tear drops.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 52 weeks to measure improvements in diabetic retinopathy severity, and for up to approximately 104 weeks to monitor for any side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07592273

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~576 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Surabgene LomparvovecShamTopical SteroidArtificial Tears

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Measured over At Week 52
+4 more outcomes measured

Conditions

Diabetic Retinopathy

Explore related trials

Non-Proliferative Diabetic RetinopathyType 1 Diabetes MellitusType 2 Diabetes Mellitus

Where it's being run

27 sites across 16 states
California6
Florida3
Texas3
Arizona2
Illinois2
Colorado1
Georgia1
Kansas1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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:
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.
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 trial measures

  • Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study EyeAt Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  • Phase 3: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study EyeAt Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  • Bilateral Portion: Bilateral portion: Number of participants experiencing ocular Adverse Events (AEs), Serious Adverse Events (SAEs), or any Adverse Events of Special Interest (AESIs)Up to Approximately Week 104

    Safety of bilateral administration with sura-vec will be assessed with Ocular AEs, SAEs, and AESIs. An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  • Bilateral Portion: Participants Who Experience Intraocular InflammationUp to Approximately Week 104

    Percentage of participants who experience intraocular inflammation.

  • Bilateral Portion: Participants Who Experience Scleral Inflammation Including EpiscleritisUp to Approximately Week 104

    Percentage of participants who experience scleral inflammation including episcleritis.