Wet Age-related Macular DegenerationPhase 1/2NCT07178249
Evaluating the Safety and Preliminary Efficacy of EXG202 Gene Therapy for Neovascular AMD
A Phase 1/2 study testing EXG202 injection in people with Wet Age-related Macular Degeneration, run by Guangzhou Jiayin Biotech Ltd.
Trial summary
VEGF inhibitors (anti-VEGF),such as aflibercept has been shown to be safe and effective for treating nAMD and have demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via intravitreal injection and can be a significant burden to the patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration
- What is being tested?
- EXG202 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2025to 30 Dec 2032
- Phase
- Phase 1/2
- 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
Who may be able to join
- Male or female, aged ≥50 years old;
- The study eye must be diagnosed of wAMD and current active lesions;
- Subjects have clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis;
- Subjects (including male subjects) have no pregnancy plans during the screening period and the entire trial period and voluntarily take effective contraceptive measures and have no sperm or egg donation plans;
- Subjects are Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; subjects have good compliance and are willing to abide by the research procedures.
Who cannot join
- The study eye has any eye disease other than wAMD that may affect central vision and/or macular detection ;
- The study eye has a history of retinal detachment or retinal detachment during the screening period;
- The study eye has MNV caused by reasons other than wAMD (such as diabetic retinopathy, pathological myopia, retinal vein occlusion, angioid streak disease, ocular histoplasmosis, trauma, etc.), and a history of macular pathology unrelated to wAMD;
- Any intraocular surgery is planned for the study eye during the study period;
- The study eye currently has retinal angiomatous proliferation (RAP), central serous chorioretinopathy or symptomatic vitreomacular traction syndrome;
- Presence of glaucoma or optic neuropathy that involves or compromises the central visual field of the study eye or presence of uncontrolled high intraocular pressure in the study eye；
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- The fellow eye meets the definition of legal blindness；
- Hormone-induced increased intraocular pressure in any eye；
- Active infection in any eye this trial (such as those who cannot understand and comply with the trial requirements or are deemed unsuitable for safety reasons).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/II Clinical Study Evaluating the Safety and Preliminary Efficacy of EXG202 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
VEGF inhibitors (anti-VEGF),such as aflibercept has been shown to be safe and effective for treating nAMD and have demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via intravitreal injection and can be a significant burden to the patients.
EXG 202 is a recombinant adeno-associated virus (rAAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein. The long-term, stable delivery of this therapeutic protein following a 1 time gene therapy treatment for nAMD could potentially reduce the treatment burden of currently available therapies while maintaining vision with a favorable benefit.
Read the detailed description
This Phase I/II study was designed to evaluate the safety and Preliminary Efficacy of EXG202 gene therapy in subjects with nAMD. Subjects who met the inclusion/exclusion criteria and had response to an initial anti-VEGF injection received a single dose of EXG202 administered . Safety was the primary focus for the phase I/II trial ,at the same time ,preliminary Efficacy also is another goal for the trial.
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- EXG202 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXG202 injectionBiological
EXG202 injection is a gene therapy product for the treatment of wet (neovascular) Age-related Macular Degeneration（wAMD） with a single intravitreal injection and administration.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation-Cohort 1 | Experimental | Dose 1 :Administered via intravitreal injection Receives: Biological: EXG202 injection |
| Dose escalation-Cohort 2 | Experimental | Dose 2 :Administered via intravitreal injection Receives: Biological: EXG202 injection |
| Dose escalation-Cohort 3 | Experimental | Dose 3 :Administered via intravitreal injection Receives: Biological: EXG202 injection |
| Dose escalation-Cohort 4 | Experimental | Dose 4 :Administered via intravitreal injection Receives: Biological: EXG202 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability after EXG202 injection
Type, severity, and incidence of adverse events (AEs) and serious adverse events (SAEs) from Week 0 to 52, and dose limited toxicity
Measured: Up to 52 weeks after treatment
Preliminary Efficancy after EXG202 injection
The Best Corrected Visual Acuity (BCVA) change from baseline
Measured: Up to 52 weeks after treatment
Secondary outcomes (1)
Safety and tolerability after EXG202 injection
Type, severity, and incidence of adverse events (AEs) and serious adverse events (SAEs) from Week 0 to 24, and dose limited toxicity
Measured: Up to 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start16 Oct 2025 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Dec 2032 (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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Jiayin Biotech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingwei ZHAO, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178249
- Sponsor's protocol ID
- EXG202-111
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study Evaluating the Safety and Preliminary Efficacy of EXG202 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT07178249
- Acronym / sponsor ID
- EXG202-111
- Conditions
- Wet Age-related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou Jiayin Biotech LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 17 Sep 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.
VEGF inhibitors (anti-VEGF),such as aflibercept has been shown to be safe and effective for treating nAMD and have demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via intravitreal injection and can be a significant burden to the patients.
EXG 202 is a recombinant adeno-associated virus (rAAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein. The long-term, stable delivery of this therapeutic protein following a 1 time gene therapy treatment for nAMD could potentially reduce the treatment burden of currently available therapies while maintaining vision with a favorable benefit.
Detailed description
This Phase I/II study was designed to evaluate the safety and Preliminary Efficacy of EXG202 gene therapy in subjects with nAMD. Subjects who met the inclusion/exclusion criteria and had response to an initial anti-VEGF injection received a single dose of EXG202 administered . Safety was the primary focus for the phase I/II trial ,at the same time ,preliminary Efficacy also is another goal for the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose escalation-Cohort 1 | Experimental | Biological: EXG202 injectionDose 1 :Administered via intravitreal injection |
| Dose escalation-Cohort 2 | Experimental | Biological: EXG202 injectionDose 2 :Administered via intravitreal injection |
| Dose escalation-Cohort 3 | Experimental | Biological: EXG202 injectionDose 3 :Administered via intravitreal injection |
| Dose escalation-Cohort 4 | Experimental | Biological: EXG202 injectionDose 4 :Administered via intravitreal injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged ≥50 years old;
- The study eye must be diagnosed of wAMD and current active lesions;
- Subjects have clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis;
- Subjects (including male subjects) have no pregnancy plans during the screening period and the entire trial period and voluntarily take effective contraceptive measures and have no sperm or egg donation plans;
- Subjects are Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; subjects have good compliance and are willing to abide by the research procedures.
Key exclusion criteria (9 listed)
- The study eye has any eye disease other than wAMD that may affect central vision and/or macular detection ;
- The study eye has a history of retinal detachment or retinal detachment during the screening period;
- The study eye has MNV caused by reasons other than wAMD (such as diabetic retinopathy, pathological myopia, retinal vein occlusion, angioid streak disease, ocular histoplasmosis, trauma, etc.), and a history of macular pathology unrelated to wAMD;
- Any intraocular surgery is planned for the study eye during the study period;
- The study eye currently has retinal angiomatous proliferation (RAP), central serous chorioretinopathy or symptomatic vitreomacular traction syndrome;
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 |
|---|---|---|
| EXG202 injectionEXG202 injection is a gene therapy product for the treatment of wet (neovascular) Age-related Macular Degeneration（wAMD） with a single intravitreal injection and administration. | Biological | Dose escalation-Cohort 1, Dose escalation-Cohort 2, Dose escalation-Cohort 3, Dose escalation-Cohort 4 |
Primary outcome
Safety and tolerability after EXG202 injection
Time frame: Up to 52 weeks after treatment
Type, severity, and incidence of adverse events (AEs) and serious adverse events (SAEs) from Week 0 to 52, and dose limited toxicity
Preliminary Efficancy after EXG202 injection
Time frame: Up to 52 weeks after treatment
The Best Corrected Visual Acuity (BCVA) change from baseline
1 secondary outcome
Safety and tolerability after EXG202 injection
Time frame: Up to 24 weeks after treatment
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 17 Sep 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
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EXG202 injection in people with Wet Age-related Macular Degeneration, run by Guangzhou Jiayin Biotech Ltd.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (13957164092, sarayang@exegenesisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability after EXG202 injection (time frame: Up to 52 weeks after treatment). The study lists 2 primary outcomes in all. 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 17 Sep 2025.