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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT02821520
Eligibility Criteria:
Inclusion Criteria:
1. Either gender，age ≥ 40.
2. BCVA at study entry of 34 to 79 letters (Snellen Equivalent 20/200 to 20/25).
3. Naive symptomatic PCV patients.
4. Presence of PCV assessed based on ICG with active polyps with or without abnormal vascular network.
5. No refractive media opacity or small pupil narrow that influence the fundus examination.
6. Women must be using effective contraception, be post-menopausal for at least months prior to trial entry, or surgically sterile.
7. Ability to provide written informed consent and to return for all study visits.
Exclusion Criteria:
1. Active inflammation or infection in the study eye.
2. Uncontrolled intraocular pressure (\>25 mmHg) in the study eye.
3. Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epiretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).
4. Presence of centro macular scarring or atrophy indicating irreversible BCVA loss.
5. Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry.
6. Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.
7. Allergy to fluorescein, ICG, iodine, shellfish.
8. Pregnant or breast-feeding women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02821520
Study Brief:
Protocol Section:
NCT02821520