Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT05903794
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, age ≥ 50 years of age;
2. Diagnosis of nAMD and current active lesion in the study eye at Screening;
3. An ETDRS BCVA letter scores between 73 and 19 letters in the study eye;
4. Response to anti-VEGF treatment during Screening;
5. The study eye must be a pseudophakic lens (post-cataract surgery status); and
6. Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening.
Exclusion Criteria:
1. Presence of any ocular disease or history of disease in the study eye other than nAMD that may affect central visual acuity and/or macular detection, including retinal detachment, or in the opinion of the investigator could limit VA improvement in the study eye;
2. Presence in the study eye of CNV or macular edema due to causes other than AMD;
3. Presence in the study eye of scarring, fibrosis or atrophy involving the macula;
4. Subretinal hemorrhage accumulating in the center of the macula of the test eye, with an area of hemorrhage ≥ 4 optic disc diameters;
5. Active ocular infection in either eye;
6. Presence of advanced glaucoma or uncontrolled glaucoma in the study eye;
7. History of intraocular surgery in the study eye within 90 days of screening; or
8. Prior receipt of any ocular or systemic gene therapy agent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05903794
Study Brief:
Protocol Section:
NCT05903794