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Gene Therapy Trial Report

Summary

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


NCTID NCT07592273 (View at clinicaltrials.gov)
Description
Development Status 🔄 Active
Indication Diabetic Retinopathy
Disease Ontology Term 🔄 DOID:8947
Compound Name 🔄 Surabgene lomparvovec
Compound Alias 🔄 ABBV-RGX-314
Sponsor AbbVie
Funder Type Industry
Recruitment Status 🔄
Enrollment Count 576 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant 🔄 Anti-VEGF
Therapy Type 🔄 Gene transfer
Therapy Route 🔄 In vivo
Mechanism of Action 🔄 Genetic delivery of therapeutic protein
Route of Administration 🔄 Suprachoroidal
Drug Product Type 🔄 Viral vector
Delivery System 🔄 Viral transduction
Vector Type 🔄 AAV8
Dose 1 🔄 Phase 2 dose: 2.5E11 GC/eye, 5.0E11 GC/eye,1.0E12 GC/eye
Dose 2 🔄 Phase 3 dose: 1.0E12 GC/eye

Study Record Dates


Current Stage Phase2, Phase3
Submit Date 2026-04-24
Completion Date 🔄 2036-01
Last Update 🔄 2026-06-15

Participation Criteria


Eligible Age >=18 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
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
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 🔄 6
Locations 🔄 Puerto Rico,United States

Regulatory Information


Has US IND True
FDA Designations
Recent Updates This product is also under evaluation for wet AMD

Resources/Links