To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)
EXG202: EXG202 is a gene therapy product for the treatment of wet (neovascular) age-related macular degeneration(wAMD) with a single intravitreal injection and administration.
Study 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).
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Male or female, aged ≥50 years old;
2. 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);
3. Clinically meaningful response to standard anti-VEGF therapy within 6 months before screening or during the lead-in period of screening.
4. 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;
5. 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;
6. 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.
Exclusion Criteria:
1. 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.);
2. 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.);
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. The study eye plans to undergo any intraocular surgery during the study period;
Primary outcome measure(s)
Safety and tolerability after EXG202 injection — up to 52 weeks after treatment 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)
Trial sites (2)
Facility
City
Region
Status
Hebei Eye Hospital
Xingtai
Hebei
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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