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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT02976194
Eligibility Criteria:
Inclusion Criteria:
1. Submacular PCV diagnosed based on branching neovascular networks having polypoidal dilatation in ICGA.
2. Presence of exudative changes involving the fovea in OCT
3. Decreased visual acuity to 20/320 - 20/40 to be primarily the results of PCV in the study eye.
4. Willing and able to comply with clinic visits and study-related procedures, and provide a signed informed consent form.
Exclusion Criteria:
1. Extramacular PCV.
2. Presence of pathologic changes blocking 50% or more area of the lesion in angiography.
3. Any anti-VEGF treatment in the study eye within 180 days of day 1.
4. Previous photodynamic therapy in the study eye.
5. History of intraocular surgery except uncomplicated cataract surgery performed before 90 days or more from day 1.
6. Presence of exudative ARMD requiring anti-VEGF treatment in the other eye.
7. Presence of other ocular disease that may compromise visual acuity in the study eye.
8. Uncontrolled systemic disease.
9. Active intraocular or periocular infection.
10. Active intraocular inflammation.
11. Hypersensitivity to ranibizumab or excipients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02976194
Study Brief:
Protocol Section:
NCT02976194