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

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.

Study Overview

• Status: Recruiting
• Conditions: Polypoidal Choroidal Vasculopathy
• Intervention / Treatment: Other: non-interventional

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

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Youxin Chen, Professor; Phone Number: +86 13801025972; Email: chenyx@pumch.cn

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100005
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Chen Youxin, Professor; Phone Number: 010-69156114; Email: chenyouxinpumch@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed as polypoid choroidal vasculopathy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Mean BCVA from baseline at the month 3, 6, 12	Routine International standard visual acuity chart, best corrected visual acuity	Through study completion, 1 year
Mean treatment pattern of aflibercept in PCV treatment	To describe the mean treatment pattern of aflibercept in PCV treatment	Through study completion, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with each treatment regimen	based on different count and describe the patients' proportion	Through study completion, 1 year
Change in CRT from baseline at month 3, 6, 12	Non-contact intraocular pressure before and after study eye injection, study eye slit lamp, ophthalmoscopy, identify the change of CRT	Through study completion, 1 year
Proportion of patients with complete regression of polyps at month 3, 6, 12	color fundus photography of the research eye, study eye ICGA angiography	Through study completion, 1 year
Proportion of patients with inactivity polyps at month 3, 6, 12	color fundus photography of the research eye, study eye ICGA angiography	Through study completion, 1 year
Proportion of patients with dry retina at month 3, 6 and 12	OCT, OCTA examination, color fundus photography of the research eye	Through study completion, 1 year
Proportion of patients with PED regression at month 3, 6 and 12	OCT, OCTA examination	Through study completion, 1 year
Mean of treatment interval and number of injections at month 12	Observe and describe the treatment pattern during routine follow-up visits	Through study completion, 1 year
Inactive polyp evaluation by OCTA at month 3, 6, 12	OCTA examination during follow-up visits	Through study completion, 1 year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Bayer
• Investigators: Study Chair: Youxin Chen, Professor, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): November 20, 2024
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Polypoidal Choroidal Vasculopathy; Aflibercept
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: CAPTAIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No