To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)

NCT06888492 | Not Yet Recruiting Early Phase 1

• 1 other identifier: EXG202-011
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of intravitreal injection of EXG202 in subjects with neovascular age-related Macular Degeneration (nAMD).

Conditions

Wet Age-related Macular Degeneration (wAMD); Wet Age-related Macular Degeneration

Keywords

wAMD; AAV

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability after EXG202 injection

  Frequency, type, and intensity of ocular and non-ocular Adverse Events (AEs) and serious adverse events (SAE) at Week 52, to explore the maximum tolerated dose (MTD)

  up to 52 weeks after treatment

Secondary Outcomes (2)

• To evaluate the efficacy after EXG202 injection

  up to 52 weeks after treatment

• To evaluate the efficacy after EXG202 injection

  52 weeks following EXG202 treatment.

Study Arms (2)

Experimental: Dose escalation-Cohort A

EXPERIMENTAL

Dose 1 :Administered via intravitreal injection

Biological: EXG202

Experimental: Dose escalation-Cohort B

EXPERIMENTAL

Dose 2 :Administered via intravitreal injection

Biological: EXG202

Interventions

EXG202 BIOLOGICAL

EXG202 is a gene therapy product for the treatment of wet (neovascular) age-related macular degeneration（wAMD） with a single intravitreal injection and administration.

Experimental: Dose escalation-Cohort A; Experimental: Dose escalation-Cohort B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥50 years old;
• The study eye must meet the following criteria:
• A. Diagnosed of wAMD and current active lesions; active, defined as the presence of any of the following lesions in the macular area upon OCT examination: a) intraretinal hemorrhage or fluid; b) subretinal fluid; c) subretinal hemorrhage; B. The BCVA score tested during screening using the ETDRS eye chart (see Appendix 3 for details) must be between 73-19 letters (including boundary values), (equivalent to Snellen visual acuity of 20/40 to 20/400);
• Clinically meaningful response to standard anti-VEGF therapy within 6 months before screening or during the lead-in period of screening.
• The subject has 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;
• Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; have good compliance and are willing to abide by the research procedures.

You may not qualify if:

• The study eye has any eye disease other than wAMD that may affect central vision and/or macular detection (such as macular hole, macular epiretinal membrane, etc.);
• The study eye has a history of retinal detachment or retinal detachment during the screening period (such as rhegmatogenous retinal detachment, tractional retinal detachment, etc.);
• 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;
• The study eye plans to undergo any intraocular surgery during the study period;

Sponsors & Collaborators

• Hangzhou Jiayin Biotech Ltd: lead

Study Sites (2)

Hebei Eye Hospital

Xingtai, Hebei, 054001, China

Location

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

Location

Central Study Contacts

Sara Yang

CONTACT

13957164092; sarayang@exegenesisbio.com

Lifei Wang, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 21, 2025
• Study Start: March 28, 2025
• Primary Completion: April 25, 2026
• Study Completion: April 30, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)