Long-term follow-up of EXG102-031 treatment for wet age-related macular degeneration
A Long-term Follow-up Study to Evaluate the Injection of EXG102-031 Ophthalmic Injection in Participants With Wet Age-related Macular Degeneration (wAMD).
This follow-up will monitor people who previously received the EXG102-031 gene therapy for wet AMD to see if the treatment remains safe and continues to work over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 42 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Guangzhou Jiayin Biotech Ltd Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06859515 on ClinicalTrials.gov |
What this trial studies
This observational follow-up enrolls participants who previously received an EXG102-031 injection in the parent EXG102-031-111 protocol and obtains informed consent for continued monitoring. No new interventions are given; visits continue the assessments from the parent study to capture safety and durability data. Visits occur every two months for the first two years and every six months from years three to five, focusing on ocular exams and functional outcomes. Continuous safety monitoring and collection of efficacy-related measures will inform long-term risk and benefit profiles for the therapy.
Who should consider this trial
Good fit: Ideal candidates are people with wet AMD who previously received EXG102-031 in the EXG102-031-111 study and who can provide informed consent and attend scheduled follow-up visits.
Not a fit: Patients who did not receive EXG102-031, or who are unable or unwilling to attend regular long-term visits, are not eligible and are unlikely to benefit from this follow-up.
Why it matters
Potential benefit: If successful, the study could confirm long-term safety and durability of EXG102-031, giving patients and clinicians clearer expectations about lasting benefits and monitoring needs.
How similar studies have performed: AAV-based gene therapies for wet AMD are early-stage and limited; some early-phase reports show potential but robust long-term safety and efficacy data are still sparse.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Peking University People's Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Mingwei ZHAO, PhD — Peking University People's Hospital
- Study coordinator: Sara Yang, MD
- Email: sarayang@exegenesisbio.com
- Phone: +86 13957164092
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.