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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2021/01/07
    • Registered Date : 2021/01/20
    • Last Updated Date : 2021/01/07
Background Information
1.Background  
CRIS Registration Number KCT0005798 
Unique Protocol ID IRB no: N-1312-001-023 
Public/Brief Title Effect of intravitreal aflibercept injection in Polypoidal Choroidal Vasculopathy 
Scientific Title Effect of intravitreal aflibercept injection in Polypoidal Choroidal Vasculopathy  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
Not applicable
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number IRB no: N-1312-001-023 
Approval Date 2014-02-13 
Institutional Review Board  
- Name Nune Eye Hospital IRB  
- Address 404, Seolleung-ro, Gangnam-gu, Seoul 
- Telephone 070-4666-1681 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name oh woong Kwon 
- Title Chief of Clinic 
- Telephone +82-2-1661-1175 
- Affiliation Nune eye hospital 
- Address Noon Bldg. 404. Seonreung-ro, Gangnam-gu, Seoul, 06198, Korea 
Contact Person for Public Queries
- Name Mi kyung Shin 
- Title Sub Investigator 
- Telephone +82-2-1661-1175 
- Affiliation Nune eye hospital 
- Address Noon Bldg. 404. Seonreung-ro, Gangnam-gu, Seoul, 06198, Korea 
Contact Person for Updating Information
- Name Hun Gu Choo 
- Title Clinical Professor 
- Telephone +82-33-741-0114 
- Affiliation Yonsei University, Wonju Severance Christian Hospital 
- Address 20, Ilsan-ro, Wonju-si, Gangwon-do, Republic of Korea 
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2014-06-24 , Actual
Target Number of Participant 30
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1 
- Name of Study Site Nune eye hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2014-06-24 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Bayer Korea 
- Organization Type Pharmaceutical Company  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Nune eye hospital 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary Polypoidal choroidal vasculopathy (PCV) is a subtype of age-related macular degeneration (AMD). It is characterized by hemorrhage, serous exudates, and scar formation, all of which can lead to permanent vision loss. The incidence of exudative AMD is particularly high among the Asian population. In the West, only 4-9.8% of all exudative AMD cases are reported to be PCV, whereas in the East, 50% of exudative AMD cases are PCV cases.
Limited studies have been conducted on the treatment regimen and natural progression of PCV compared with classic AMD. Studies on anti-vascular endothelial growth factor (VEGF) therapy have established it as a first-line therapy for AMD. However, whether the treatment should be used as a first-line therapy for treating PCV remains controversial.
Since the release of aflibercept, however, many studies have reported that aflibercept monotherapy yielded favorable functional outcomes and a favorable polyp closure rate when used to treat PCV
Therefore, through this study, it is intended to be helpful in establishing a protocol for treatment of PCV by confirming the results of aflibercept monotherapy with a fixed regimen in patients with PCV  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Not applicable 
Intervention Model Single Group  
Blinding/Masking Open 
Allocation Not Applicable 
Intervention Type Drug  
Intervention Description Each patient received aflibercept (2.0 mg) injections (fixed dosing) in an aseptic operation room. For the loading phase, each patient was administered with an aflibercept injection once a month for three months; subsequently, maintenance injections were administered every two months. For 12 months, seven injections were administered at baseline and at the one-, two-, four-, six-, eight-, and ten-month follow-up visits.
At every follow-up visit after the initial baseline visit, best-corrected visual acuity (BCVA) was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart; intraocular pressure measurement, slit lamp examination, fundus photography, and optical coherence tomography (Spectralis, Heidelberg Engineering, Heidelberg, Germany) were performed as well. At baseline and at four and 12 months, fluorescein and indocyanine green angiography (ICGA) (HRA system; Heidelberg Engineering, Heidelberg, Germany) were performed.  
Number of Arms
Arm 1 Arm Label Polypoidal choroidal vasculopathy patients 
Target Number of Participant 30 
Arm Type Experimental 
Arm Description Each patient received aflibercept (2.0 mg) injections (fixed dosing) in an aseptic operation room. For the loading phase, each patient was administered with an aflibercept injection once a month for three months; subsequently, maintenance injections were administered every two months. For 12 months, seven injections were administered at baseline and at the one-, two-, four-, six-, eight-, and ten-month follow-up visits. At every follow-up visit after the initial baseline visit, best-corrected visual acuity (BCVA) was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart; intraocular pressure measurement, slit lamp examination, fundus photography, and optical coherence tomography (Spectralis, Heidelberg Engineering, Heidelberg, Germany) were performed as well. At baseline and at four and 12 months, fluorescein and indocyanine green angiography (ICGA) (HRA system; Heidelberg Engineering, Heidelberg, Germany) were performed. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of the eye and adnexa
Polypoidal Choroidal Vasculopathy  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age No Limit ~ No Limit
Description Patients with confirmed Polypoidal Choroidal Vasculopathy by indocyanine green angiography
Optical coherence tomography shows subretina or intraretina fluid
Best corrected visual acuity between 20/200 and 20/20
Patients 3 months after the last intravitreal injection treatment  
Exclusion Criteria Patients with retinal diseases other than age-related macular degeneration
Patients who have a history of intraocular surgery, excluding cataract surgery
Patients with a history of glaucoma
Patients with a history of eye inflammation, such as uveitis  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome Mean change in BCVA from baseline to 12 months 
- Timepoint 12 months visit 
Primary Outcome(s) 2 
- Outcome Proportion of patients who had complete intraretinal/subretinal fluid resolution after 12 months 
- Timepoint 12 months visit 
Primary Outcome(s) 3 
- Outcome Proportion of patients who had complete polypoidal lesion disappearance after 12 months 
- Timepoint 12 months visit 
Secondary Outcome(s) 1 
- Outcome proportion of patients with visual acuity of 20/40 or higher after 12 months, 
- Timepoint 12 months visit 
Secondary Outcome(s) 2 
- Outcome Pproportion of patients with improved visual acuity of 15 letters or more after 12 months 
- Timepoint 12 months visit 
Secondary Outcome(s) 3 
- Outcome Change in retinal thickness from bas,eline to 12 months 
- Timepoint 12 months visit 
Secondary Outcome(s) 4 
- Outcome Change in average number of polyps from baseline to 12 months 
- Timepoint 12 months visit 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No