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

Purpose

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.

Condition

  • Diabetic Retinopathy

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Surabgene Lomparvovec
    Solution Injection
  • Drug: Topical Steroid
    Topical Drops
Experimental
Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B 		Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B.
  • Drug: Surabgene Lomparvovec
    Solution Injection
  • Drug: Topical Steroid
    Topical Drops
Placebo Comparator
Phase 2b: Sham + Artificial Tears -Regimen A 		Participants will receive a single injection of sham+ artificial tears -Regimen A.
  • Drug: Sham
    needleless injection without fluid
  • Drug: Artificial Tears
    Topical Drops
Placebo Comparator
Phase 2b: Sham + Artificial Tears -Regimen B 		Participants will receive a single injection of Sham+ artificial tears -Regimen B.
  • Drug: Sham
    needleless injection without fluid
  • Drug: Artificial Tears
    Topical Drops
Experimental
Phase 3: Surabgene Lomparvovec + Steroid 		Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
  • Drug: Surabgene Lomparvovec
    Solution Injection
  • Drug: Topical Steroid
    Topical Drops
Placebo Comparator
Phase 3: Sham + Artificial Tears 		Participants will receive a single injection of Sham + artificial tears.
  • Drug: Sham
    needleless injection without fluid
  • Drug: Artificial Tears
    Topical Drops
Experimental
Bilateral: B1-Surabgene Lomparvovec + Steroid 		Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye.
  • Drug: Surabgene Lomparvovec
    Solution Injection
  • Drug: Topical Steroid
    Topical Drops
Experimental
Bilateral: B2-Surabgene Lomparvovec + Steroid 		Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye.
  • Drug: Surabgene Lomparvovec
    Solution Injection
  • Drug: Topical Steroid
    Topical Drops

Recruiting Locations

University Retina - Oak Forest /ID# 283021
Oak Forest, Illinois 60452

Austin Research Center for Retina /ID# 276101
Austin, Texas 78705

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com