NCT06859515

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
56mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Mar 2025Dec 2030

First Submitted

Initial submission to the registry

February 28, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

March 13, 2025

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2030

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

5.2 years

First QC Date

February 28, 2025

Last Update Submit

August 14, 2025

Conditions

Wet Age-related Macular Degeneration

Keywords

AAVwAMD

Outcome Measures

Primary Outcomes (1)

  • long-term safety：the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs).

    the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs).

    4 years

Secondary Outcomes (3)

  • Change from baseline after treatment by EXG102-031：best corrected visual acuity (BCVA)

    4 years

  • Change from baseline after treatment by EXG102-031：central retinal thickness (CRT)

    4 years

  • The times of receiving anti-vascular endothelial growth factor (VEGF) therapy after EXG102-031 administrated

    4 years

Interventions

No intervention, only for observational studiesOTHER

No intervention, only for observational studies

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Previously received treatment with EXG102-031 in the study (EXG102-031-111);
  • Paticipantes are informed consent and willingness to follow protocol procedures.

You may not qualify if:

  • \. Paticipantes are unwilling or unable to participate in long-term follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Single Person

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Mingwei ZHAO, PhD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Yang, MD

CONTACT

+86 13957164092sarayang@exegenesisbio.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 5, 2025

Study Start

March 13, 2025

Primary Completion (Estimated)

May 15, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)