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

NCT ID: NCT06859515

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-13

Study Completion Date

2030-12-01

Brief Summary

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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

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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.

Conditions

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Wet Age-related Macular Degeneration

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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No intervention, only for observational studies

No intervention, only for observational studies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role collaborator

Hangzhou Jiayin Biotech Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mingwei ZHAO, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Sara Yang, MD

Role: CONTACT

+86 13957164092

Other Identifiers

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EXG102-031-111-LTFU

Identifier Type: -

Identifier Source: org_study_id

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