Clinical Implication of Aflibercept in PCV Treatment in China (NCT05639660) | Clinical Trial Compass
UnknownNot Applicable
Clinical Implication of Aflibercept in PCV Treatment in China
China1,000 participantsStarted 2021-01-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years, gender, unilateral or bilateral onset
✓. Treatment-experienced or treatment-naïve patients diagnosed with PCV after ICGA examination
✓. Signed informed consent, able to long-term follow-up
✓. 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
✕. Patients with anterior segment (including iris and angle) neovascularization or neovascular glaucoma
✕. Received oral or intravenous antiangiogenic drugs within 180 days prior to the screening visit
✕. The study eye has a history of idiopathic or autoimmune uveitis
✕. Study eyes with active ocular inflammation or evidence of infectious blepharitis, corneal inflammation, scleritis, or conjunctivitis
✕. The 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 infection
✕. Patients with uncontrolled blood pressure (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg when the subject is sitting)
✕
What they're measuring
1
Change of Mean BCVA from baseline at the month 3, 6, 12
Timeframe: Through study completion, 1 year
2
Mean treatment pattern of aflibercept in PCV treatment