Recruiting
Phase 2
Phase 3

Sura-Vec

Sponsor:

AbbVie

Code:

NCT07592273

Conditions

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surabgene Lomparvovec

Sham

Topical Steroid

Artificial Tears

Study Details

Brief 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.

Conditions

Diabetic Retinopathy

Study ID

NCT07592273

Start date

Jun 1, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2036

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

576 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Surabgene Lomparvovec

Solution Injection

Sham

needleless injection without fluid

Topical Steroid

Topical Drops

Artificial Tears

Topical Drops

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 ]
  • Phase 3: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye [ Time Frame: At Week 52 ]
  • Bilateral Portion: Bilateral portion: Number of participants experiencing ocular Adverse Events (AEs), Serious Adverse Events (SAEs), or any Adverse Events of Special Interest (AESIs) [ Time Frame: Up to Approximately Week 104 ]
  • Bilateral Portion: Participants Who Experience Intraocular Inflammation [ Time Frame: Up to Approximately Week 104 ]
  • Bilateral Portion: Participants Who Experience Scleral Inflammation Including Episcleritis [ Time Frame: Up to Approximately Week 104 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

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

Recruiting

Phoenix, Arizona, United States, 85053

Retina Macula Institute of Arizona /ID# 282881

Recruiting

Scottsdale, Arizona, United States, 85255-4134

California Retina Consultants - Bakersfield /ID# 282990

Recruiting

Bakersfield, California, United States, 93309

The Retina Partners /ID# 274741

Recruiting

Encino, California, United States, 91436

Northern California Retina Vitreous Associates /ID# 282994

Recruiting

Mountain View, California, United States, 94040-4119

California Eye Specialists Medical Group /ID# 274705

Recruiting

Pasadena, California, United States, 91107

Retina Consultants San Diego /ID# 274748

Recruiting

Poway, California, United States, 92064

West Coast Retinal Medical Group /ID# 283007

Recruiting

San Francisco, California, United States, 94109

Macula Retina Vitreous Center - Torrance /ID# 282878

Recruiting

Torrance, California, United States, 90503

Southwest Retina Research Center /ID# 276094

Recruiting

Durango, Colorado, United States, 81303

Colorado Retina Associates /ID# 283006

Recruiting

Lakewood, Colorado, United States, 80228

Florida Retina Consultants - Lakeland /ID# 275012

Recruiting

Lakeland, Florida, United States, 33805

Florida Retina Institute - Orlando /ID# 283034

Recruiting

Orlando, Florida, United States, 32806

Retina Speciality Institute /ID# 274996

Recruiting

Pensacola, Florida, United States, 32503

Southeast Retina Center /ID# 274739

Recruiting

Augusta, Georgia, United States, 30909

Illinois Retina Associates S.C /ID# 283048

Recruiting

Chicago, Illinois, United States, 60657

University Retina - Oak Forest /ID# 283021

Recruiting

Oak Forest, Illinois, United States, 60452

Springfield Clinic - First /ID# 283028

Recruiting

Springfield, Illinois, United States, 62702

Retina Associates - Lenexa /ID# 283004

Recruiting

Lenexa, Kansas, United States, 66215

Maine Eye Center - Marginal Way Campus /ID# 275039

Recruiting

Portland, Maine, United States, 04101

Mid Atlantic Retina Specialists - Hagerstown /ID# 274725

Recruiting

Hagerstown, Maryland, United States, 21740

Sierra Eye Associates /ID# 274737

Recruiting

Reno, Nevada, United States, 89502

Retina Center Of New Jersey /ID# 283088

Recruiting

Bloomfield, New Jersey, United States, 07003

Retina Associates Of Cleveland - Beachwood /ID# 275985

Recruiting

Beachwood, Ohio, United States, 44122

Charleston Neuroscience Institute - Charleston /ID# 275047

Recruiting

Charleston, South Carolina, United States, 29414

Austin Research Center for Retina /ID# 276101

Recruiting

Austin, Texas, United States, 78705

Star Retina /ID# 276513

Recruiting

Burleson, Texas, United States, 76028

Texas Retina Associates - Dallas /ID# 276117

Recruiting

Dallas, Texas, United States, 75231

Vistar Eye Center - Salem /ID# 282879

Recruiting

Salem, Virginia, United States, 24153

More Information

Sponsor

AbbVie

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Diabetic Retinopathy
  • Severe Nonproliferative Diabetic Retinopathy
  • ABBV-RGX-314

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-03.