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Gene Therapy Trial Report

Summary

A Study of EXG102-031 in Patients With wAMD (Everest)


NCTID NCT05903794 (View at clinicaltrials.gov)
Description
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 (ESTIMATED)
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
Delivery System Viral transduction
Vector Type AAV8
Editor Type none
Dose 1 Undisclosed dose 1
Dose 2 Undisclosed dose 2

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
Eligibility Criteria
Inclusion Criteria: 1. Male or female, age ≥ 50 years of age; 2. Diagnosis of nAMD and current active lesion in the study eye at Screening; 3. An ETDRS BCVA letter scores between 73 and 19 letters in the study eye; 4. Response to anti-VEGF treatment during Screening; 5. The study eye must be a pseudophakic lens (post-cataract surgery status); and 6. Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening. Exclusion Criteria: 1. Presence of any ocular disease or history of disease in the study eye other than nAMD that may affect central visual acuity and/or macular detection, including retinal detachment, or in the opinion of the investigator could limit VA improvement in the study eye; 2. Presence in the study eye of CNV or macular edema due to causes other than AMD; 3. Presence in the study eye of scarring, fibrosis or atrophy involving the macula; 4. Subretinal hemorrhage accumulating in the center of the macula of the test eye, with an area of hemorrhage ≥ 4 optic disc diameters; 5. Active ocular infection in either eye; 6. Presence of advanced glaucoma or uncontrolled glaucoma in the study eye; 7. History of intraocular surgery in the study eye within 90 days of screening; or 8. Prior receipt of any ocular or systemic gene therapy agent.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

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