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To compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy
The subjects were classified into two subtypes (type 1 and type 2 polypoidal choroidal vasculopathy) based on the presence or the absence of both of a feeder and a draining vessels on indocyanine green angiography. All received intravitreal injection of aflibercept (2.0 mg) at baseline and months 1, 2 and 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 polypoidal choroidal vasculopathy | Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate. |
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| Type 2 polypoidal choroidal vasculopathy | Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Total 4 times of intravitreal aflibercept injection was performed |
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| Measure | Description | Time Frame |
|---|---|---|
| Regression Rate of Polyp on Indocyanine Green Angiography | Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased >30%. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | Best corrected visual acuity assessed at baseline, 3 months, and 6 months | baseline, 3 months, and 6 monthsc |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients were recruited from the retinal clinic of the Yeungnam university hospital. Recruitment started on October 01 2015 to March 31 2016.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeungnam University College of Medicine | Daegu | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27597740 | Derived | Jeong S, Sagong M. Short-term efficacy of intravitreal aflibercept depending on angiographic classification of polypoidal choroidal vasculopathy. Br J Ophthalmol. 2017 Jun;101(6):758-763. doi: 10.1136/bjophthalmol-2016-309144. Epub 2016 Sep 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 1 Polypoidal Choroidal Vasculopathy | Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate. Aflibercept: Total 4 times of intravitreal aflibercept injection was performed Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Indocyanine green angiography (intraveonus indocyanine green dye) | Drug | At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure. |
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| FG001 | Type 2 Polypoidal Choroidal Vasculopathy | Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate. Aflibercept: Total 4 times of intravitreal aflibercept injection was performed Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Type 1 Polypoidal Choroidal Vasculopathy | Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection. At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure. |
| BG001 | Type 2 Polypoidal Choroidal Vasculopathy | Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection. At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Regression Rate of Polyp on Indocyanine Green Angiography | Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased >30%. | Participants who were finished 6 months follow up period. | Posted | Number | participants | 3 months |
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| Secondary | Best Corrected Visual Acuity | Best corrected visual acuity assessed at baseline, 3 months, and 6 months | Participants who were finished 6 months follow up period. | Posted | Mean | Standard Deviation | LogMAR | baseline, 3 months, and 6 monthsc |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Type 1 Polypoidal Choroidal Vasculopathy | Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection. At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure. | 0 | 18 | 0 | 18 | ||
| EG001 | Type 2 Polypoidal Choroidal Vasculopathy | Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection. At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure. | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Min Sagong | Yeungnam University College of Medicine | 82-53-620-4191 | msagong@ynu.ac.kr |
| ID | Term |
|---|---|
| D000092342 | Polypoidal Choroidal Vasculopathy |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Male |
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| No regression |
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