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
| Arm | Description | Assigned 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. |
|
|
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. |
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|
Placebo Comparator Phase 2b: Sham + Artificial Tears -Regimen B |
Participants will receive a single injection of Sham+ artificial tears -Regimen B. |
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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. |
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|
Experimental Bilateral: B2-Surabgene Lomparvovec + Steroid |
Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye. |
|
Recruiting Locations
Phoenix, Arizona 85053
Scottsdale, Arizona 85255-4134
Bakersfield, California 93309
Encino, California 91436
Mountain View, California 94040-4119
Pasadena, California 91107
Poway, California 92064
Torrance, California 90503
Durango, Colorado 81303
Lakeland, Florida 33805
Orlando, Florida 32806
Pensacola, Florida 32503
Augusta, Georgia 30909
Oak Forest, Illinois 60452
Springfield, Illinois 62702
Lenexa, Kansas 66215
Portland, Maine 04101
Hagerstown, Maryland 21740
Reno, Nevada 89502
Bloomfield, New Jersey 07003
Beachwood, Ohio 44122
Charleston, South Carolina 29414
Austin, Texas 78705
Burleson, Texas 76028
Dallas, Texas 75231
Salem, Virginia 24153
Arecibo, Puerto Rico 00612
More Details
- Status
- Recruiting
- Sponsor
- AbbVie