Actively Recruiting
A Long-term Follow-up Study to Evaluate the Injection of EXG102-031 Ophthalmic Injection in Participants With Wet Age-related Macular Degeneration (wAMD)
Led by Guangzhou Jiayin Biotech Ltd · Updated on 2025-08-15
42
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
Sponsors
G
Guangzhou Jiayin Biotech Ltd
Lead Sponsor
P
Peking University People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and efficacy of EXG102-031 ophthalmic injection in patients with wet age-related macular degeneration (wAMD) who have previously received this gene therapy treatment. This study focuses on monitoring patients over several years to understand any lasting effects and safety concerns after the initial treatment. Participants in this observational study will continue visits from the parent EXG102-031-111 clinical trial and voluntarily join this follow-up phase. For the first two years, follow-up visits occur every two months, then every six months from year three through five. No new interventions are administered during this follow-up; the study is designed to observe and assess ongoing outcomes. During the study, participants will undergo regular safety monitoring to track any serious or adverse events. Researchers will also evaluate changes in visual acuity, retinal thickness, and the frequency of additional anti-VEGF therapy after the initial EXG102-031 administration. The study lasts up to five years, providing continuous observation of participants' health and vision status.
CONDITIONS
Brief Title
A Long-term Follow up Study of EXG102-031 in Participants With wAMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously received treatment with EXG102-031 in the study (EXG102-031-111)
- Participants are informed consent and willingness to follow protocol procedures
You will not qualify if you...
- Participants are unwilling or unable to participate in long-term follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants who have previously been treated with EXG102-031 are followed to evaluate long-term safety and efficacy.
Visits every 2 months for the first 2 years, then every 6 months from year 3 to year 5
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
S
Sara Yang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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