Long-term follow-up of EXG102-031 treatment for wet age-related macular degeneration
Official title: A Long-term Follow-up Study to Evaluate the Injection of EXG102-031 Ophthalmic Injection in Participants With Wet Age-related Macular Degeneration (wAMD).
Run by Guangzhou Jiayin Biotech Ltd · NCT06859515 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Guangzhou Jiayin Biotech Ltd Industry-sponsored |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | March 13, 2025 |
| Main results expected | May 15, 2030 |
| Study ends | December 1, 2030 |
| Registry record updated | August 15, 2025 |
| Trial ID | NCT06859515 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Topical NT-101 in wet age-related macular degeneration
A topical eye drop (NT-101) is being tested to see if it can help people 50 and older with wet AMD when used twice daily for 12 weeks.
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Comparing 8-week and 12-week follow-up intervals for treating wet AMD with faricimab
This study is testing whether patients with wet age-related macular degeneration can benefit more from follow-up treatments every 8 weeks or every 12 weeks after their initial injections of faricimab.
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Low-dose oral doxycycline targeting MMP-9 for persistent wet AMD
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EYC-0305 in Neovascular (Wet) AMD: First-in-Patients Safety and Tolerability Study
This study tests whether EYC-0305 given as an eye injection every 24 weeks is safe and tolerable in people 50 and older with wet AMD.
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AIV007 Periocular Shot for Wet AMD
This trial tests whether a periocular injection of AIV007 can improve vision and safety in people with wet age-related macular degeneration, compared with the standard Eylea injections.
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Long-term follow-up for patients with wet age-related macular degeneration receiving SKG0106
This study is testing how well and safely the treatment SKG0106 works for people with wet age-related macular degeneration over a long period after their last injection.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.