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RecruitingPhase 2/Phase 3

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

AbbVie · NCT07592273

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
576
US sites recruiting
37
Study start
June 1, 2026
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Surabgene Lomparvovec; Sham; Topical Steroid; Artificial Tears

Conditions: Diabetic Retinopathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Barnet Dulaney Perkins Eye Center - Mesa /ID# 283000

    Mesa, AZ 85206

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

    Phoenix, AZ 85053

  • Retina Macula Institute of Arizona /ID# 282881

    Scottsdale, AZ 85255-4134

  • California Retina Consultants - Bakersfield /ID# 282990

    Bakersfield, CA 93309

  • Retina-Vitreous Associates Medical Group - Beverly Hills /ID# 282995

    Beverly Hills, CA 90211

  • Retinal Diagnostic Center /ID# 275055

    Campbell, CA 95008

  • The Retina Partners /ID# 274741

    Encino, CA 91436

  • Northern California Retina Vitreous Associates /ID# 282994

    Mountain View, CA 94040-4119

  • California Eye Specialists Medical Group /ID# 274705

    Pasadena, CA 91107

  • Retina Consultants San Diego /ID# 274748

    Poway, CA 92064

  • West Coast Retinal Medical Group /ID# 283007

    San Francisco, CA 94109

  • Macula Retina Vitreous Center - Torrance /ID# 282878

    Torrance, CA 90503

  • Bay Area Retina Associates /ID# 275032

    Walnut Creek, CA 94598-5910

  • Southwest Retina Research Center /ID# 276094

    Durango, CO 81303

  • Colorado Retina Associates /ID# 283006

    Lakewood, CO 80228

  • Advanced Vision Surgery Center /ID# 275017

    Longmont, CO 80503

  • Florida Retina Consultants - Lakeland /ID# 275012

    Lakeland, FL 33805

  • Florida Retina Institute - Orlando /ID# 283034

    Orlando, FL 32806

  • Retina Speciality Institute /ID# 274996

    Pensacola, FL 32503

  • Southeast Retina Center /ID# 274739

    Augusta, GA 30909

  • Illinois Retina Associates S.C /ID# 283048

    Chicago, IL 60657

  • University Retina - Lemont /ID# 283021

    Lemont, IL 60439

  • Springfield Clinic - First /ID# 283028

    Springfield, IL 62702

  • Retina Associates - Lenexa /ID# 283004

    Lenexa, KS 66215

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

    Portland, ME 04101

  • Mid Atlantic Retina Specialists - Hagerstown /ID# 274725

    Hagerstown, MD 21740

  • Sierra Eye Associates /ID# 274737

    Reno, NV 89502

  • Retina Center Of New Jersey /ID# 283088

    Bloomfield, NJ 07003

  • Retina Associates Of Cleveland - Middleburg Heights Office /ID# 275985

    Middleburg Heights, OH 44130

  • Retina Northwest /ID# 283232

    Portland, OR 97221

    Site contact: Site Coordinator · 215-662-8675

  • Charleston Neuroscience Institute - Charleston /ID# 275047

    Charleston, SC 29414

  • Austin Research Center for Retina /ID# 276101

    Austin, TX 78705

  • Retina and Vitreous of Texas /ID# 283051

    Bellaire, TX 77401

  • Star Retina /ID# 276513

    Burleson, TX 76028

  • Texas Retina Associates - Dallas /ID# 276117

    Dallas, TX 75231

  • Wagner Macula & Retina Center - Norfolk /ID# 275021

    Norfolk, VA 23502

  • Vistar Eye Center - Salem /ID# 282879

    Salem, VA 24153

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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Surabgene Lomparvovec Administered in the Suprachoroidal Space in… (NCT07592273) | Bored Studies