Clinical Implication of Aflibercept in PCV Treatment in China

NCT05639660 | Unknown DMC

• 1 other identifier: CAPTAIN
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

Polypoidal Choroidal Vasculopathy; Aflibercept

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Proportion of patients with each treatment regimen

  Through study completion, 1 year

• Change in CRT from baseline at month 3, 6, 12

  Through study completion, 1 year

• Proportion of patients with complete regression of polyps at month 3, 6, 12

  Through study completion, 1 year

• Proportion of patients with inactivity polyps at month 3, 6, 12

  Through study completion, 1 year

• Proportion of patients with dry retina at month 3, 6 and 12

  Through study completion, 1 year

Study Arms (1)

Aflibercept group

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

Other: non-interventional

Interventions

non-interventional 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.

Aflibercept group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed as polypoid choroidal vasculopathy.

You may qualify if:

• 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

You may not qualify if:

• 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)
• Cerebrovascular accident and/or myocardial infarction within 180 days prior to the screening visit
• Patients with renal insufficiency undergoing renal dialysis, renal failure requiring dialysis or renal transplantation
• 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
• 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
• Participated in any drug (except vitamins and minerals) or device therapy study within 30 days prior to the screening visit
• The patient has received other anti-VEGF therapy within 30 days
• Other patients deemed necessary to be excluded by the investigator

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Bayer: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Youxin Chen, Professor

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Youxin Chen, Professor

CONTACT

+86 13801025972; chenyx@pumch.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: December 6, 2022
• Study Start: January 1, 2021
• Primary Completion: November 20, 2024
• Study Completion: November 30, 2024
• Last Updated: December 6, 2022

Record last verified: 2022-10

Locations

CN (1)