CClinicalTrials.gg
Not yet recruitingNCT07178249Updated Sep 17, 2025

Evaluating the Safety and Preliminary Efficacy of EXG202 Gene Therapy for Neovascular AMD

A Phase 1/2 interventional study of EXG202 injection in Wet Age-related Macular Degeneration, sponsored by Guangzhou Jiayin Biotech Ltd. Not yet recruiting. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Guangzhou Jiayin Biotech Ltd · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Wet Age-related Macular Degeneration
03

In context

Lead sponsor

Guangzhou Jiayin Biotech Ltd is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, aged ≥50 years old;
  2. The study eye must be diagnosed of wAMD and current active lesions;
  3. Subjects have clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis;
  4. 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;
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. The study eye has any eye disease other than wAMD that may affect central vision and/or macular detection ;
  2. The study eye has a history of retinal detachment or retinal detachment during the screening period;
  3. 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;
  4. Any intraocular surgery is planned for the study eye during the study period;
  5. The study eye currently has retinal angiomatous proliferation (RAP), central serous chorioretinopathy or symptomatic vitreomacular traction syndrome;
  6. 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;
  7. The fellow eye meets the definition of legal blindness;
  8. Hormone-induced increased intraocular pressure in any eye;
  9. 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).
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Dose escalation-Cohort 1

    Dose 1 :Administered via intravitreal injection

    Biological: EXG202 injection

  • Experimental
    Dose escalation-Cohort 2

    Dose 2 :Administered via intravitreal injection

    Biological: EXG202 injection

  • Experimental
    Dose escalation-Cohort 3

    Dose 3 :Administered via intravitreal injection

    Biological: EXG202 injection

  • Experimental
    Dose escalation-Cohort 4

    Dose 4 :Administered via intravitreal injection

    Biological: EXG202 injection

Interventions

  • BiologicalEXG202 injection

    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.

06

What researchers measure

Primary 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 52, and dose limited toxicity

    Time frame: Up to 52 weeks after treatment

  2. Preliminary Efficancy after EXG202 injection

    The Best Corrected Visual Acuity (BCVA) change from baseline

    Time frame: 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

    Time frame: Up to 24 weeks after treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07178249
Lead sponsor
Guangzhou Jiayin Biotech Ltd
Responsible party
Sponsor
First posted
Sep 17, 2025
Start date
Oct 16, 2025 (estimated)
Primary completion
Feb 28, 2028 (estimated)
Completion
Dec 30, 2032 (estimated)
Last update
Sep 17, 2025

Study contacts

Sara Yang
Contact
sarayang@exegenesisbio.com
13957164092
Mingwei ZHAO, PhD
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Guangzhou Jiayin Biotech Ltd

Start the discussion