Clinical trial NCT05639660: Clinical Implication of Aflibercept in PCV Treatment in China
Official title: Aflibercept Observational Study for the Clinical Use of PCV in China, Polycentric, Observational, Retrospective-prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polypoidal Choroidal Vasculopathy
Keywords: Polypoidal Choroidal Vasculopathy
Aflibercept
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2022-12-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed as polypoid choroidal vasculopathy.

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

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

Primary outcomes:
measure: Change of Mean BCVA from baseline at the month 3, 6, 12
timeFrame: Through study completion, 1 year
measure: Mean treatment pattern of aflibercept in PCV treatment
timeFrame: Through study completion, 1 year
Secondary outcomes:
measure: Proportion of patients with each treatment regimen
timeFrame: Through study completion, 1 year
measure: Change in CRT from baseline at month 3, 6, 12
timeFrame: Through study completion, 1 year
measure: Proportion of patients with complete regression of polyps at month 3, 6, 12
timeFrame: Through study completion, 1 year
measure: Proportion of patients with inactivity polyps at month 3, 6, 12
timeFrame: Through study completion, 1 year
measure: Proportion of patients with dry retina at month 3, 6 and 12
timeFrame: Through study completion, 1 year
measure: Proportion of patients with PED regression at month 3, 6 and 12
timeFrame: Through study completion, 1 year
measure: Mean of treatment interval and number of injections at month 12
timeFrame: Through study completion, 1 year
measure: Inactive polyp evaluation by OCTA at month 3, 6, 12
timeFrame: Through study completion, 1 year
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Youxin Chen, Professor
role: STUDY_CHAIR
References: