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:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT04246866
Eligibility Criteria:
Inclusion Criteria:
1. At least 50 years old at the time of signed informed consent
2. Able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment and provide informed consent prior to initiation of any study procedure
3. Best corrected visual acuity (BCVA) in study eye between 5-45 letters
4. Confirmed diagnosis of central GA in the study eye and eligible total GA lesion size
Exclusion Criteria:
1. Presence of the following ocular conditions - in the study eye:
* Exudative AMD or choroidal neovascularization (CNV)
* Any ocular disease or condition that could impact the subject's ability to participate in the study or be a contraindication to IVT injection
* Any intraocular surgery (with the exception of intraocular lens replacement surgery more than 3 months prior to consent)
2. Presence of any of the following ocular conditions - in either eye:
* History of herpetic infection
* Ongoing treatment with antiangiogenic therapies in the fellow eye or completed treatment in the study eye
3. Any prior or ongoing medical condition (e.g. ocular other than dry AMD, systemic, psychiatric) or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period
4. Female subjects must not be pregnant or lactating
5. Current use of medications known to be toxic to the lens, retina, or optic nerve
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04246866
Study Brief:
Protocol Section:
NCT04246866