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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT05639660
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years, gender, unilateral or bilateral onset
2. Treatment-experienced or treatment-naïve patients diagnosed with PCV after ICGA examination
3. Signed informed consent, able to long-term follow-up
4. PCV patients previously treated with aflibercept were enrolled as retrospective cases, and PCV patients previously treated with other anti-VEGF, at least 1 month since the last treatment
Exclusion Criteria:
1. Patients with anterior segment (including iris and angle) neovascularization or neovascular glaucoma
2. Received oral or intravenous antiangiogenic drugs within 180 days prior to the screening visit
3. The study eye has a history of idiopathic or autoimmune uveitis
4. Study eyes with active ocular inflammation or evidence of infectious blepharitis, corneal inflammation, scleritis, or conjunctivitis
5. The patient has a coagulation disorder or is taking oral warfarin, Plavix (clopidogrel) and other similar anticoagulation drugs.
6. The patient is receiving treatment for severe systemic infection
7. Patients with uncontrolled blood pressure (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg when the subject is sitting)
8. Cerebrovascular accident and/or myocardial infarction within 180 days prior to the screening visit
9. Patients with renal insufficiency undergoing renal dialysis, renal failure requiring dialysis or renal transplantation
10. The investigator believes that based on the history of other diseases, metabolic dysfunction, physical examination results or clinical laboratory results, patients have a disease or condition that will increase the risk for complications from treatment
11. Pregnant or lactating women; women of childbearing potential with positive pregnancy test results at baseline or not receiving pregnancy test; postmenopausal women must have been amenorrhea for at least 12 months to not be considered fertile
12. Participated in any drug (except vitamins and minerals) or device therapy study within 30 days prior to the screening visit
13. The patient has received other anti-VEGF therapy within 30 days
14. Other patients deemed necessary to be excluded by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05639660
Study Brief:
Protocol Section:
NCT05639660