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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT04684394
Eligibility Criteria:
Inclusion Criteria:
1. At least 50 years old at the time of signed informed consent
2. Choroidal neovascularization (CNV) related to nAMD with the following features, as determined by the Image Reading Center
1. Maximum CNV lesion size of 12 disc areas
2. Subretinal hemorrhage less than or equal to (\<=) 50% of lesion size
3. On aflibercept treatment prior to Day 1
4. Best Corrected Visual Acuity (BCVA) in the study eye between 24 to 75 letters using EDTRS
Exclusion Criteria:
1. Presence of the following ocular conditions in the study eye:
1. Any active ocular disease or condition that impact the subject to participate in the study or be a contraindication of IVT injections
2. Any intraocular surgery
3. Aphakia or complete absence of the posterior capsule
4. Prior corneal transplant
5. Scar or fibrosis greater than or equal to (\>=) 50% of CNV lesion or involving center of fovea
2. Presence of any of the following ocular conditions in either eye:
1. History of herpetic infection, idiopathic polypoidal choroidal vasculopathy (PCV), pathologic myopia, central serous chorioretinopathy (CSCR), adult onset foveal pattern dystrophy
2. Concurrent disease that could require medical or surgical intervention during the study period
3. Active/suspected ocular/periocular infection or active intraocular inflammation
4. History of idiopathic or autoimmune-associated uveitis
3. Any prior or ongoing medical condition 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. Has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent
5. Females must not be pregnant or lactating
6. Current use of medications known to be toxic to the lens, retina or optic nerve
7. Use of any investigational new drug or other experimental treatment in the last 6 months prior to Day 1, and/or receipt of any prior gene therapy or ocular device implantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04684394
Study Brief:
Protocol Section:
NCT04684394