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NCT Number: NCT06859515

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

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Key information

Conditions

Wet Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

No intervention, only for observational studies

Other

No intervention, only for observational studies

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Yang, MD

CONTACT

[email protected]

+86 13957164092

Sponsors and collaborators

Lead sponsor

Guangzhou Jiayin Biotech Ltd

Industry

Collaborators

  • Peking University People's Hospital

Registry information

Official study 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).

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 5, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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