Clinical Implication of Aflibercept in PCV Treatment in China

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Nov 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Aflibercept to treat a condition known as Polypoidal Choroidal Vasculopathy (PCV) in patients across China. The goal is to see how effective Aflibercept is in improving vision in people diagnosed with PCV. The study will involve around 1,000 patients from 30 different hospitals, and researchers will monitor the patients over a long period to gather important data about their eyesight changes after treatment.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with PCV. Both new patients and those who have already received treatment for PCV can join, as long as they meet other health criteria. Participants will need to provide consent and can expect regular follow-ups to track their vision improvement. It's important to note that certain individuals with specific health issues, such as severe infections or recent heart problems, may not be eligible to participate. Overall, this study aims to better understand how Aflibercept can help improve the quality of life for patients with PCV.

Gender

ALL

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

Trial Officials