A Long-term Follow up Study of EXG102-031 in Participants With wAMD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention, only for observational studies.
- Who it may be relevant to
- Registry conditions: Wet Age-related Macular Degeneration. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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).
Overview
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.
Detailed 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.
Interventions
- Other No intervention, only for observational studies
No intervention, only for observational studies
Primary outcome measures
- long-term safety：the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs). [Time frame: 4 years]
Secondary outcome measures (3)
- Change from baseline after treatment by EXG102-031：best corrected visual acuity (BCVA) [Time frame: 4 years]
- Change from baseline after treatment by EXG102-031：central retinal thickness (CRT) [Time frame: 4 years]
- The times of receiving anti-vascular endothelial growth factor (VEGF) therapy after EXG102-031 administrated [Time frame: 4 years]
Eligibility criteria
Inclusion criteria
- Previously received treatment with EXG102-031 in the study (EXG102-031-111);
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06859515 · EXG102-031-111-LTFU