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

Launched by HANGZHOU JIAYIN BIOTECH LTD · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called EXG202, which is given as an injection into the eye. The goal is to see if this treatment is safe and effective for people with wet age-related macular degeneration (wAMD), a condition that can cause vision loss. The trial is not recruiting participants yet, but they are looking for people who are at least 50 years old and have specific eye conditions related to wAMD. Participants should have had a positive response to standard treatments for wAMD in the past six months.

If you join this trial, you will receive the EXG202 injection and will be monitored for your eye health and vision changes. It's important to note that certain eye conditions or surgeries may exclude you from participating. Additionally, male participants must agree to use contraception during the study period. This trial aims to find out if EXG202 can help improve vision in people suffering from wAMD, providing hope for better treatment options in the future.

Gender

ALL

Eligibility criteria

• 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;