NCT05639660

Clinical Implication of Aflibercept in PCV Treatment in China

Aflibercept Observational Study for the Clinical Use of PCV in China, Polycentric, Observational, Retrospective-prospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Study Objective(s) To provide overall treatment characteristics of aflibercept in PCV treatment Secondary Study Objective(s) 1. To describe the treatment regimens of aflibercept treatment on PCV in clinical practice. 2. To evaluate effectiveness of aflibercept treatment on PCV including vision gain (BCVA) and anatomic improvement (CRT, Polyps regression, Polyps inactivity, and PED) 3. To explore the relative factors of aflibercept treatment effectiveness. 4. To describe patients' tolerance to anti-VEGF and PDT treatment. 5. To collect safety information with aflibercept treatment in a wider population setting

Conditions

• Polypoidal Choroidal Vasculopathy

Interventions

Type	Name	Description
OTHER	non-interventional	The treatment guideline recommends the 3+Q2m regimen for Aflibercept, but this study is an observational study, no intervention is made in the subjects' treatment regimen. There is no prescribed visit plan. According to the decision of the doctor and the patient according to the treatment plan, the patient needs to come to the clinic within the prescribed time window (3, 6, and 12 months) to facilitate the recording of data.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-11-20
• Completion: 2024-11-30
• First posted: 2022-12-06
• Last updated: 2022-12-06

Locations

1 site across 1 country: China