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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
A Study of EXG102-031 in Patients With wAMD (Everest)
NCTID
NCT05903794
(View at clinicaltrials.gov)
Description
In neovascular (wet) age-related macular degeneration (nAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with nAMD.
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Development Status
Active
Indication
Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term
DOID:10871
Compound Name
EXG102-031
Sponsor
Exegenesis Bio
Funder Type
Industry
Recruitment Status
Active not recruiting
Enrollment Count
12
Results Posted
Not Available
Therapy Information
Target Gene/Variant
ABD-VEGFR
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
Undisclosed dose 1
Dose 2
Undisclosed dose 2
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1
Submit Date
2023-06-06
Completion Date
2026-02-28
Last Update
2025-04-17
Participation Criteria
Eligible Age
>=50 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
2
Locations
United States
Regulatory Information
Has US IND
True
FDA Designations
Recent Updates
FDA cleared IND 1/18/23
Resources/Links
News and Press Releases
Exegenesis Bio Announces FDA Clearance of Investigational New Drug (IND) Application for EXG102-031: A Novel Gene Therapy for the Treatment of neovascular Age-Related Macular Degeneration (nAMD)
Preclinical Publications
(Abstract) Efficacy Evaluation of EXG102-031, A Novel AAV-based Gene Therapy for Neovascular AMD in a Mouse Model of VEGF-A-induced Exudative Retinal Detachment vascular leakage Mouse Model - ARVO 2023
Related NCTID
Long Term Follow-Up: NCT06817343
Long Term Follow-Up: NCT06859515