Surabgene Lomparvovec in the Suprachoroidal Space for Diabetic Retinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial investigates a single-dose gene therapy delivered into the suprachoroidal space for adults with moderately severe to severe NPDR without center-involved DME. The study includes Phase 2b, Phase 3, and bilateral treatment portions, enrolling about 576 participants across multiple sites in the US and Puerto Rico. Participants may receive sura-vec with prophylactic steroids or compare with sham treatment and standard eye care. Outcomes focus on safety and the ability to prevent vision-threatening events associated with diabetic retinopathy. Eligible participants have good baseline visual acuity and NPDR severity with the option to defer certain treatments for at least six months.

Why it matters

Who can join: the full rules

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

Where it's running

• Barnet Dulaney Perkins Eye Center - Mesa /ID# 283000
  Mesa, Arizona, United States Recruiting
• Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
  Phoenix, Arizona, United States Recruiting
• Retina Macula Institute of Arizona /ID# 282881
  Scottsdale, Arizona, United States Recruiting
• California Retina Consultants - Bakersfield /ID# 282990
  Bakersfield, California, United States Recruiting
• Retina-Vitreous Associates Medical Group - Beverly Hills /ID# 282995
  Beverly Hills, California, United States Recruiting
• Retinal Diagnostic Center /ID# 275055
  Campbell, California, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy

  This trial tests whether intravitreal corticosteroid injections can influence inflammatory biomarkers and improve DME in adults with type 2 diabetes.

  Recruiting Phase 4 Vanderbilt University Medical Center · Nashville, Tennessee · NCT07843849

• Automated detection of diabetic retinopathy lesions in fundus photos

  This study tests a smart imaging system within the DDART device to see if it can reliably spot diabetic retinopathy lesions in color fundus photographs.

  Recruiting Democritus University of Thrace · Alexandroupoli · NCT07758582

• Retinal microvascular changes in diabetic retinopathy measured with OCTA

  This observational study tests how retinal blood vessel patterns seen on OCTA relate to vision and blood sugar control in adults with diabetic retinopathy.

  Recruiting Sohag University · Sohag · NCT07747428

• MK-8748 vs. aflibercept for diabetic macular edema

  This trial tests whether the investigational medicine MK-8748 can treat diabetic macular edema as well as the standard treatment aflibercept in adults with diabetes.

  Recruiting at 20 sites Phase 3 Merck Sharp & Dohme LLC · Long Beach, California and 19 other locations · NCT07705607

• MK-8748 vs aflibercept for diabetic macular edema

  This trial tests whether MK-8748 can treat diabetic macular edema as well as the standard treatment aflibercept in people with diabetes.

  Recruiting at 35 sites Phase 3 Merck Sharp & Dohme LLC · Gilbert, Arizona and 34 other locations · NCT07705555

• RO7663498 eye injection safety in diabetic retinopathy

  This study tests the safety, tolerability, and how the drug behaves in the body after an intravitreal injection for people with diabetic retinopathy.

  Recruiting at 4 sites Phase 1 Hoffmann-La Roche · Glendale, California and 3 other locations · NCT07588100

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.