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

Last updated: June 24, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2/3

Condition

Diabetic Retinopathy

Treatment

Topical Steroid

Sham

Artificial Tears

Clinical Study ID

NCT07592273
M23-415
  • Ages > 18
  • All Genders

Study 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

Inclusion

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) (earlytreatment diabetic retinopathy study-diabetic retinopathy severity scale [DRSS]level 47 or 53) for which panretinal photocoagulation (PRP) or anti- vascularendothelial growth factor (VEGF) can be safely deferred for at least 6 months afterScreening Visit 1.

  • Best-corrected visual acuity (BCVA) in the study eye of >= 69 Early treatmentdiabetic 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

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 eyeas determined by spectral domain optical coherence tomography (SD-OCT) evaluated bythe 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 orScreening Visit 2

  • Neovascularization from a cause other than DR, per investigator

  • Evidence or documented history of panretinal photocoagulation (PRP) or retinal lasertherapy

  • History of intravitreal therapy, including anti-VEGF and long- or short-actingsteroid therapy, within the prior 6 months and documentation of more than 10 prioranti-VEGF or short acting steroid intravitreal injections within 36 months ofScreening Visit 1

  • Pregnant and breastfeeding individuals are excluded from this clinical study.

Systemic

  • Initiation of intensive insulin treatment (pump or multiple daily injections) withinthe 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 monthsprior 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

Study Design

Total Participants: 576
Treatment Group(s): 4
Primary Treatment: Topical Steroid
Phase: 2/3
Study Start date:
June 01, 2026
Estimated Completion Date:
January 31, 2036

Connect with a study center

  • Emanuelli Research & Development Center /ID# 275378

    Arecibo, 00612
    Puerto Rico

    Active - Recruiting

  • Northern California Retina Vitreous Associates /ID# 282994

    Mountain View, California 94040-4119
    United States

    Active - Recruiting

  • Florida Retina Consultants - Lakeland /ID# 275012

    Lakeland, Florida 33805
    United States

    Active - Recruiting

  • University Retina - Oak Forest /ID# 283021

    Oak Forest, Illinois 60452
    United States

    Active - Recruiting

  • Sierra Eye Associates /ID# 274737

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Retina Associates Of Cleveland - Beachwood /ID# 275985

    Beachwood, Ohio 44122
    United States

    Active - Recruiting

  • Austin Research Center for Retina /ID# 276101

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Texas Retina Associates - Dallas /ID# 276117

    Dallas, Texas 75231
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.