Health TrialsbyHealthPanel

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

ConditionWet Age-related Macular Degeneration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorGuangzhou Jiayin Biotech Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Previously received treatment with EXG102-031 in the study (EXG102-031-111);

Paticipantes are informed consent and willingness to follow protocol procedures.

Disqualifiers

None

Trial population

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

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • No intervention, only for observational studies

    Other intervention

    No intervention, only for observational studies

Treatment groups

No treatment groups listed

Trial outcomes

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).

Time frame
4 years

Secondary outcomes

1

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

Use the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart evaluated. The higher values means better outcome.

Time frame
4 years
2

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

evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT). The higher values means worse outcome.

Time frame
4 years
3

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

The more times means worse outcome

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou Jiayin Biotech Ltd

Lead sponsor

Peking University People's Hospital

Collaborator

Source ClinicalTrials.gov
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