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

August 14, 2025 updated by: Hangzhou Jiayin Biotech Ltd

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

wAMD patients who have previously been treated with EXG102-031 injection in the study (EXG102-031-111).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
long-term safety：the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs).
Time Frame: 4 years
the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs).
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline after treatment by EXG102-031：best corrected visual acuity (BCVA)
Time Frame: 4 years
Use the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart evaluated. The higher values means better outcome.
4 years
Change from baseline after treatment by EXG102-031：central retinal thickness (CRT)
Time Frame: 4 years
evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT). The higher values means worse outcome.
4 years
The times of receiving anti-vascular endothelial growth factor (VEGF) therapy after EXG102-031 administrated
Time Frame: 4 years
The more times means worse outcome
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Jiayin Biotech Ltd

Collaborators

Peking University People's Hospital

Investigators

  • Principal Investigator: Mingwei ZHAO, PhD, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

May 15, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXG102-031-111-LTFU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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