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Gene therapy shot aims to stop diabetic eye disease in its tracks

NCT ID NCT07592273

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 21 times

Summary

This study tests a one-time gene therapy called surabgene lomparvovec (Sura-vec) for diabetic retinopathy, a common eye problem from diabetes that can lead to blindness. About 576 adults with moderate-to-severe non-proliferative diabetic retinopathy will receive either the gene therapy or a sham procedure. The goal is to see if the treatment can improve the retina and prevent vision-threatening events over five years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surabgene lomparvovec (Sura-vec)
What this could lead to
If successful, this one-time gene therapy could prevent vision loss and reduce the need for repeated eye injections in people with diabetic retinopathy.
What could go wrong
This is an early-to-mid stage trial with only 576 participants. The therapy involves a novel injection method and requires steroid use, which may cause side effects like inflammation. It may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 576 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jan 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

background diabetic retinopathy diabetic retinopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic retinopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Vision Surgery Center /ID# 275017

    RECRUITING

    Longmont, Colorado, 80503, United States

  • Austin Research Center for Retina /ID# 276101

    RECRUITING

    Austin, Texas, 78705, United States

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

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Bay Area Retina Associates /ID# 275032

    RECRUITING

    Walnut Creek, California, 94598-5910, United States

  • California Eye Specialists Medical Group /ID# 274705

    RECRUITING

    Pasadena, California, 91107, United States

  • California Retina Consultants - Bakersfield /ID# 282990

    RECRUITING

    Bakersfield, California, 93309, United States

  • Charleston Neuroscience Institute - Charleston /ID# 275047

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • Colorado Retina Associates /ID# 283006

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • Emanuelli Research & Development Center /ID# 275378

    RECRUITING

    Arecibo, 00612, Puerto Rico

  • Florida Retina Consultants - Lakeland /ID# 275012

    RECRUITING

    Lakeland, Florida, 33805, United States

  • Florida Retina Institute - Orlando /ID# 283034

    RECRUITING

    Orlando, Florida, 32806, United States

  • Illinois Retina Associates S.C /ID# 283048

    RECRUITING

    Chicago, Illinois, 60657, United States

  • Macula Retina Vitreous Center - Torrance /ID# 282878

    RECRUITING

    Torrance, California, 90503, United States

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

    RECRUITING

    Portland, Maine, 04101, United States

  • Mid Atlantic Retina Specialists - Hagerstown /ID# 274725

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Northern California Retina Vitreous Associates /ID# 282994

    RECRUITING

    Mountain View, California, 94040-4119, United States

  • Retina Associates - Lenexa /ID# 283004

    RECRUITING

    Lenexa, Kansas, 66215, United States

  • Retina Associates Of Cleveland - Beachwood /ID# 275985

    RECRUITING

    Beachwood, Ohio, 44122, United States

  • Retina Center Of New Jersey /ID# 283088

    RECRUITING

    Bloomfield, New Jersey, 07003, United States

  • Retina Consultants San Diego /ID# 274748

    RECRUITING

    Poway, California, 92064, United States

  • Retina Macula Institute of Arizona /ID# 282881

    RECRUITING

    Scottsdale, Arizona, 85255-4134, United States

  • Retina Speciality Institute /ID# 274996

    RECRUITING

    Pensacola, Florida, 32503, United States

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

    RECRUITING

    Phoenix, Arizona, 85053, United States

  • Sierra Eye Associates /ID# 274737

    RECRUITING

    Reno, Nevada, 89502, United States

  • Southeast Retina Center /ID# 274739

    RECRUITING

    Augusta, Georgia, 30909, United States

  • Southwest Retina Research Center /ID# 276094

    RECRUITING

    Durango, Colorado, 81303, United States

  • Springfield Clinic - First /ID# 283028

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Star Retina /ID# 276513

    RECRUITING

    Burleson, Texas, 76028, United States

  • Texas Retina Associates - Dallas /ID# 276117

    RECRUITING

    Dallas, Texas, 75231, United States

  • The Retina Partners /ID# 274741

    RECRUITING

    Encino, California, 91436, United States

  • University Retina - Oak Forest /ID# 283021

    RECRUITING

    Oak Forest, Illinois, 60452, United States

  • Vistar Eye Center - Salem /ID# 282879

    RECRUITING

    Salem, Virginia, 24153, United States

  • West Coast Retinal Medical Group /ID# 283007

    RECRUITING

    San Francisco, California, 94109, United States

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