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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT02769169
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 50 years and ≤80;
* Active PCV confirmed by ICGA+FFA (Indocyanine green angiography + fundus fluorescein angiography);
* At least one distinguishable polyp was shown in ICGA;
* BCVA between 24 to 73 letters with ETDRS chart (Early Treatment of Diabetic Retinopathty Study);
* The greatest linear dimension of the lesion \<5400μm.
Exclusion Criteria:
* Previously received treatment of laser retina photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood or any investigational treatment;
* Previous photodynamic therapy or anti-Vegf treatment within 6 months in study eye
* Previously received treatment of photodynamic treatment within 1 month, or any anti-vascular endothelial growth factor (VEGF) intraocular injection in 3 months in the fellow eye;
* Combine of current vitreous hemorrhage or extensive subretinal hemorrhage (lesion area \>30mm2);
* A history of angioid streaks, presumed ocular histoplasmosis syndrome or pathologic myopia;
* Experienced retinal pigmental epithelium (RPE) tear, retinal detachment, macular hole or uncontrolled glaucoma;
* Undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation);
* Cataract extraction with intraocular lens implantation within 60 days;
* Combine of cataract that could require medical or surgical intervention during 12 months;
* Combine of diabetes mellitus and have poor glucose control (Haemoglobin A1c (HbA1c) \>8%);
* Combine of hypertension and have poor blood pressure control (blood pressure ≥140/95 mmHg after regular antihypertensive drugs treatment);
* History of myocardial infarction or cerebral infarction in last 6 months;
* During gestation period or lactation period;
* Combine of confirmed systemic autoimmune disease or any uncontrollable clinical conditions (e.g. HIV, malignant tumor, active hepatitis, severe systemic disease, diseases need immediately surgical treatment).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT02769169
Study Brief:
Protocol Section:
NCT02769169