A Long-term Follow up Study of EXG102-031 in Participants With wAMD

Hangzhou Jiayin Biotech

Status: Enrolling

Conditions: Wet Age-related Macular Degeneration

Treatments: Other: No intervention, only for observational studies

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06859515

EXG102-031-111-LTFU

Details and patient eligibility

About

This is a long-term, safety and efficacy follow-up study of patients in the EXG102-031-111 gene therapy clinical trial for wAMD. Patients will complete visits from the parent study, and then into this long-term follow-up study for continuous safety monitoring for up to 5 years.

Full description

This study will enroll patients with wet age-related macular degeneration (wAMD) who have previously be treated with EXG102-031 injection, those patients will Voluntary join this long-term follow-up study to be evaluated the long-term safety and efficacy.

The first two years of long-term follow-up will be conducted every 2 months; From 3 years to 5 years after administration,follow-up visits will be conducted every six months.

Enrollment: 42 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Previously received treatment with EXG102-031 in the study (EXG102-031-111);
2. Paticipantes are informed consent and willingness to follow protocol procedures.

Exclusion criteria

1. Paticipantes are unwilling or unable to participate in long-term follow-up