Wet Age-related Macular DegenerationNCT06859515
A Long-term Follow up Study of EXG102-031 in Participants With wAMD
An observational study of Wet Age-related Macular Degeneration, run by Guangzhou Jiayin Biotech Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2025to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: wAMD patients who have previously been treated with EXG102-031 injection in the study (EXG102-031-111).
Who may be able to join
- Previously received treatment with EXG102-031 in the study (EXG102-031-111);
- Paticipantes are informed consent and willingness to follow protocol procedures.
Who cannot join
- 1. Paticipantes are unwilling or unable to participate in long-term follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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).
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.
Read the 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.
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- No intervention, only for observational studies
- Keywords
- AAV, wAMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, only for observational studiesOther
No intervention, only for observational studies
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 years
Secondary outcomes (3)
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.
Measured: 4 years
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.
Measured: 4 years
The times of receiving anti-vascular endothelial growth factor (VEGF) therapy after EXG102-031 administrated
The more times means worse outcome
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start13 Mar 2025
- Primary completion15 May 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Jiayin Biotech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Responsible party
- Sponsor
- Investigators
- Mingwei ZHAO, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859515
- Sponsor's protocol ID
- EXG102-031-111-LTFU
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT06859515
- Acronym / sponsor ID
- EXG102-031-111-LTFU
- Conditions
- Wet Age-related Macular Degeneration
- Keywords
- AAV, wAMD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Guangzhou Jiayin Biotech LtdIndustry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 15 May 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- wAMD patients who have previously been treated with EXG102-031 injection in the study (EXG102-031-111).
Key inclusion criteria (2 listed)
- Previously received treatment with EXG102-031 in the study (EXG102-031-111);
- Paticipantes are informed consent and willingness to follow protocol procedures.
Key exclusion criteria (1 listed)
- 1. Paticipantes are unwilling or unable to participate in long-term follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, only for observational studiesNo intervention, only for observational studies | Other | – |
Primary outcome
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).
3 secondary outcomes
Change from baseline after treatment by EXG102-031：best corrected visual acuity (BCVA)
Time frame: 4 years
Change from baseline after treatment by EXG102-031：central retinal thickness (CRT)
Time frame: 4 years
The times of receiving anti-vascular endothelial growth factor (VEGF) therapy after EXG102-031 administrated
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mingwei ZHAO, PhD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Age-related Macular Degeneration, run by Guangzhou Jiayin Biotech Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Yang, MD (+86 13957164092, sarayang@exegenesisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-term safety：the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs). (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.