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Clinical Trial Report

Gene Therapy Trial Report

Summary

NG101 AAV Gene Therapy in Subjects with Wet Age-Related Macular Degeneration

NCTID NCT05984927 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term DOID:10871
Compound Name NG101
Sponsor Neuracle Genetics, Inc
Funder Type Industry
Recruitment Status
Recruiting
Enrollment Count 18
Results Posted Not Available

Therapy Information

Target Gene/Variant Codon optimized aflibercept
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Genetic delivery of therapeutic protein
Route of Administration Subretinal
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV8
Editor Type none
Dose 1 1E9 vg
Dose 2 3E9 vg
Dose 3 8E9 vg
Dose 4
Dose 5

Study Record Dates

Current Stage Phase1, Phase2
Submit Date 2023-07-24
Completion Date 2030-01
Last Update 2025-03-27

Participation Criteria

Eligible Age 50 Years - 89 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations

No.of Trial Sites 4
Locations Canada,United States

Regulatory Information

Has US IND True
FDA Designations Fast Track
Recent Updates Plans to expand trial into the USA

Resources/Links

News and Press Releases
Preclinical Publications