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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
Drug Product Name EXG102-031
Sponsor Exegenesis Bio
Funder Type Industry
Recruitment Status 🔄
Completed
Enrollment Count 12 (ACTUAL)
Results Posted Not Available

Therapy Information


Target Gene/Variant ABD-VEGFR
Therapeutic Modality Gene transfer
Therapy Route in vivo
Mechanism of Action Genetic delivery of therapeutic protein
Route of Administration Subretinal
Drug Product Type Viral vector
Gene Delivery System Type Viral transduction
Vector Type AAV8
Dose 1 🔄 Undisclosed dose escalation, 2 levels

Study Record Dates


Current Phase Phase1
Submit Date 2023-06-06
Completion Date 🔄 2026-02-16
Last Update 🔄 2026-04-08

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