Clinical Implication of Aflibercept in PCV Treatment in China

NCT ID: NCT05639660

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-11-30

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Aflibercept group

Single arm, Aflibercept 2.0mg/0.05ml, intravitreal injection

non-interventional

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Youxin Chen, Professor

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Youxin Chen, Professor

Role: CONTACT

chenyx@pumch.cn

+86 13801025972

Facility Contacts

Chen Youxin, Professor

Role: primary

chenyouxinpumch@163.com

010-69156114

Other Identifiers

CAPTAIN

Identifier Type: -

Identifier Source: org_study_id