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

Last updated: September 15, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2/3

Condition

Diabetic Retinopathy

Treatment

Sham

Artificial Tears

Surabgene Lomparvovec

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: Sham
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

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

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • Retina Macula Institute of Arizona /ID# 282881

    Scottsdale, Arizona 85255-4134
    United States

    Active - Recruiting

  • Barnet Dulaney Perkins Eye Center - Sun City /ID# 283000

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • California Retina Consultants - Bakersfield /ID# 282990

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • The Retina Partners /ID# 274741

    Encino, California 91436
    United States

    Active - Recruiting

  • Northern California Retina Vitreous Associates /ID# 282994

    Mountain View, California 94040-4119
    United States

    Active - Recruiting

  • California Eye Specialists Medical Group /ID# 274705

    Pasadena, California 91107
    United States

    Active - Recruiting

  • Retina Consultants San Diego /ID# 274748

    Poway, California 92064
    United States

    Active - Recruiting

  • West Coast Retinal Medical Group /ID# 283007

    San Francisco, California 94109
    United States

    Active - Recruiting

  • Macula Retina Vitreous Center - Torrance /ID# 282878

    Torrance, California 90503
    United States

    Active - Recruiting

  • Bay Area Retina Associates /ID# 275032

    Walnut Creek, California 94598-5910
    United States

    Active - Recruiting

  • Southwest Retina Research Center /ID# 276094

    Durango, Colorado 81303
    United States

    Active - Recruiting

  • Colorado Retina Associates /ID# 283006

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Advanced Vision Surgery Center /ID# 275017

    Longmont, Colorado 80503
    United States

    Active - Recruiting

  • Florida Retina Consultants - Lakeland /ID# 275012

    Lakeland, Florida 33805
    United States

    Active - Recruiting

  • Florida Retina Institute - Orlando /ID# 283034

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Retina Speciality Institute /ID# 274996

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Southeast Retina Center /ID# 274739

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • Illinois Retina Associates S.C /ID# 283048

    Chicago, Illinois 60657
    United States

    Active - Recruiting

  • University Retina - Oak Forest /ID# 283021

    Oak Forest, Illinois 60452
    United States

    Active - Recruiting

  • Springfield Clinic - First /ID# 283028

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Retina Associates - Lenexa /ID# 283004

    Lenexa, Kansas 66215
    United States

    Active - Recruiting

  • Maine Eye Center - Marginal Way Campus /ID# 275039

    Portland, Maine 04101
    United States

    Active - Recruiting

  • Mid Atlantic Retina Specialists - Hagerstown /ID# 274725

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Sierra Eye Associates /ID# 274737

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Retina Center Of New Jersey /ID# 283088

    Bloomfield, New Jersey 07003
    United States

    Active - Recruiting

  • Retina Associates Of Cleveland - Beachwood /ID# 275985

    Beachwood, Ohio 44122
    United States

    Active - Recruiting

  • Charleston Neuroscience Institute - Charleston /ID# 275047

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Austin Research Center for Retina /ID# 276101

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Star Retina /ID# 276513

    Burleson, Texas 76028
    United States

    Active - Recruiting

  • Texas Retina Associates - Dallas /ID# 276117

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Vistar Eye Center - Salem /ID# 282879

    Salem, Virginia 24153
    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.