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Recruiting NCT05639660

Clinical Implication of Aflibercept in PCV Treatment in China

Conditions: Polypoidal Choroidal Vasculopathy

Sex: All
Ages: 18 Years – N/A
Enrollment: 1000
Sponsor: Peking Union Medical College Hospital

Location: China

Summary

The purpose of this study is to evaluate the overall treatment characteristics and efficacy of Aflibercept in the treatment of PCV in China through a multicenter, observational, prospective-retrospective study. This study is a long-term follow-up cohort, plans to unite a total of 30 hospitals in different regions of the China to enroll 1000 PCV patients.Main evaluation indicators: To observe the changes in visual acuity (BCVA) in PCV patients treated with Aflibercept to evaluate the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria:Age ≥ 18 years, gender, unilateral or bilateral onsetTreatment-experienced or treatment-naïve patients diagnosed with PCV after ICGA examinationSigned informed consent, able to long-term follow-upPCV 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 treatmentExclusion Criteria:Patients with anterior segment (including iris and angle) neovascularization or neovascular glaucomaReceived oral or intravenous antiangiogenic drugs within 180 days prior to the screening visitThe study eye has a history of idiopathic or autoimmune uveitisStudy eyes with active ocular inflammation or evidence of infectious blepharitis, corneal inflammation, scleritis, or conjunctivitisThe patient has a coagulation disorder or is taking oral warfarin, Plavix (clopidogrel) and other similar anticoagulation drugs.The patient is receiving treatment for severe systemic infectionPatients with uncontrolled blood pressure (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg when the subject is sitting)Cerebrovascular accident and/or myocardial infarction within 180 days prior to the screening visitPatients with renal insufficiency undergoing renal dialysis, renal failure requiring dialysis or renal transplantationThe 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 treatmentPregnant 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 fertileParticipated in any drug (except vitamins and minerals) or device therapy study within 30 days prior to the screening visitThe patient has received other anti-VEGF therapy within 30 daysOther patients deemed necessary to be excluded by the investigator

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05639660). StuddyBuddy aggregates publicly available trial information.