Status:
RECRUITING
A Study of EXG102-031 in Participants With wAMD
Lead Sponsor:
Hangzhou Jiayin Biotech Ltd
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
In neovascular (wet) age-related macular degeneration (wAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and...
Detailed Description
Age-related macular degeneration (AMD) is a major cause of blindness and visual impairment in older adults. The wet form of AMD, also called neovascular AMD (nAMD) usually causes faster vision loss th...
Eligibility Criteria
Inclusion
- Male or female, age ≥ 50 years of age;
- Diagnosis of wAMD and current active lesion in the study eye at Screening;
- An ETDRS BCVA letter scores between 73 and 9 letters in the study eye;
- Response to anti-VEGF treatment within 6 months prior to screening or at the time of screening introduction;
- The study eye must be a Intraocular lens eye(post-cataract surgery status) and be at least 1 month post IOL implantation at enrollment;
- Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening.
Exclusion
- Presence of any ocular disease or history of disease in the study eye other than wAMD that may affect central visual acuity and/or macular detection;
- Presence in the study eye of CNV or macular pathology pathography due to causes other than wAMD;
- The study eye has severe and irreversible retinal structural damage involving the fovea (such as retinal pigment epithelial (RPE) atrophy, retinal fibrosis, laser scars, dense hard exudation); Or other retinal damage in the target eye that, in the opinion of the investigator, may impede visual improvement after resolution of macular edema ;
- Subretinal hemorrhage accumulating the central fovea of the study eye, with an area of hemorrhage ≥ 4 optic disc diameters;
- Presence of advanced glaucoma or uncontrolled ocular hypertension in the study eye;
- Prior receipt of any ocular or systemic gene therapy agent.
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06183814
Start Date
October 12 2023
End Date
December 31 2025
Last Update
January 9 2024
Active Locations (8)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100000
2
Beijing Tongren Hospital,Cmu
Beijing, Beijing Municipality, China, 100000
3
Peking University People'S Hospital
Beijing, Beijing Municipality, China, 100000
4
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China