NCT07592273 Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
| NCT ID | NCT07592273 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | AbbVie |
| Condition | Diabetic Retinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 576 participants |
| Start Date | 2026-05-20 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 576 participants in total. It began in 2026-05-20 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT07592273 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Retinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07592273 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07592273 currently recruiting?
Yes, NCT07592273 is actively recruiting participants. Contact the research team at abbvieclinicaltrials@abbvie.com for enrollment information.
Where is the NCT07592273 trial being conducted?
This trial is being conducted at Mountain View, United States, Oak Forest, United States, Austin, United States.
Who is sponsoring the NCT07592273 clinical trial?
NCT07592273 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 576 participants.