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Gene Therapy Trial Report

Summary

RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)


NCTID NCT04567550 (View at clinicaltrials.gov)
Description
Development Status 🔄 Active
Indication Diabetic Retinopathy (DR), Center-Involved Diabetic Macular Edema (CI-DME)
Disease Ontology Term 🔄 DOID:9191; DOID:8947
Compound Name 🔄 ABBV-RGX-314
Compound Alias 🔄 surabgene lomparvovec
Sponsor AbbVie
Funder Type Industry
Recruitment Status
Active not recruiting
Enrollment Count 139 (ACTUAL)
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 🔄 2.5E11 GC/eye
Dose 2 🔄 5.0E11 GC/eye
Dose 3 🔄 1.0E12 GC/eye

Study Record Dates


Current Stage Phase2
Submit Date 2020-09-15
Completion Date 2026-12
Last Update 2025-09-17

Participation Criteria


Eligible Age 25 Years - 89 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
Part 1 (DR without CI-DME): Inclusion Criteria: * Patients 25-89 years of age with a diabetic retinopathy (DR) diagnosis of nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) secondary to diabetes mellitus Type 1 or 2 for which PRP or anti-VEGF injections can be safely deferred for at least 6 months * HbA1c \< 12%. * Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better). * Prior history of CI-DME in the study eye is acceptable. * Must be willing and able to provide written, signed informed consent. Exclusion Criteria: * Neovascularization in the study eye from a cause other than DR. * Presence of any active CI-DME. * Active or history of retinal detachment in the study eye. * Any evidence or documented history of PRP or retinal laser in the study eye. * Patients who had a prior vitrectomy surgery. * Women of childbearing potential. Part 2 (DR with CI-DME): Inclusion Criteria: * Patients 25-89 years of age with diabetic retinopathy secondary to diabetes mellitus Type 1 or 2. * HbA1c \< 12% * Macular thickening secondary to DME involving the center of the fovea, CST on SD-OCT (≥ 325 μm) * Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of 78-25 letters (approximate Snellen equivalent of 20/32 to 20/320) * Participants must have demonstrated a meaningful response to anti-VEGF therapy. * Must be willing and able to provide written, signed informed consent Exclusion Criteria: * Neovascularization in the study eye from a cause other than DR. * Active or history of retinal detachment in the study eye. * Any evidence or documented history of PRP or retinal laser in the study eye. * Patients who had a prior vitrectomy surgery. * Women of childbearing potential. Note: Other inclusions/exclusions criteria apply.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 25
Locations United States

Regulatory Information


Has US IND True
FDA Designations
Recent Updates

Resources/Links