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Clinical Trial Report

Gene Therapy Trial Report

Summary

Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy

NCTID NCT06018558 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Geographic Atrophy
Disease Ontology Term DOID:10871
Compound Name OCU410
Sponsor Ocugen
Funder Type Industry
Recruitment Status
Recruiting
Enrollment Count 63
Results Posted Not Available

Therapy Information

Target Gene/Variant RORA
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Subretinal
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV5
Editor Type none
Dose 1 2.5E10 vg/mL
Dose 2 5E10 vg/mL
Dose 3 1.5E11 vg/mL
Dose 4
Dose 5

Study Record Dates

Current Stage Phase1, Phase2
Submit Date 2023-06-30
Completion Date 2025-09-23
Last Update 2025-03-20

Participation Criteria

Eligible Age >=50 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations

No.of Trial Sites 9
Locations United States

Regulatory Information

Has US IND True
FDA Designations
Recent Updates Dosing complete in the Phase 2 clinical trial

Resources/Links

News and Press Releases
Preclinical Publications