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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy (PCV) will be evaluated.
Efficacy of VEGF Trap-Eye (aflibercept, Eylea) for exudative age-related macular degeneration (AMD) was demonstrated in the phase III VIEW study. Polypoidal choroidal vasculopathy (PCV) is considered as a subtype of exudative AMD, however it is reportedly different from choroidal new vessels based on the histologic studies. The aim of this study is to evaluate effects of VEGF Trap-Eye in treatment of PCV, which was diagnosed using indocyanine green (ICG) angiography. VEGF Trap-Eye will be injected intravitreally bimonthly after 3 monthly loading dose for 12 months in treatment-naive PCV patients. The efficacy will be evaluated on preserving visual acuity and improving angiographic features at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aflibercept | Experimental | Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aflibercept | Drug | Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Lose Visual Acuity Less Than 15 Letters | Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity From Baseline to 12 Months | Mean changes of visual acuity in ETDRS letters. Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. A change of 5 letters is equivalent to a 1-line change. | Baseline and 12 months |
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Inclusion Criteria:
Submacular PCV diagnosed using ICG angiography with no previous treatment (branching vascular network with or without polypoidal dilation in ICG angiography)
Presence of signs of recent activity of PCV
Exclusion Criteria:
Extramacular PCV
Subretinal hemorrhage or other retinal lesions blocking angiographic characteristics in more than 50% area of PCV lesion.
Previous treatment of intravitreal injections (anti-VEGF, steroid or other agents)
Previous treatment of photodynamic therapy
Previous ocular surgery except cataract surgery before 3 or more months
Presence of exudative AMD in the other eyes requiring anti-VEGF treatment (Intravitreal bevacizumab was reported to affect the other eye.)
Presence of other ocular diseases which may affect visual acuity (glaucoma, cataract with opacity involving visual axis, etc)
Presence of uncontrolled systemic disease (diabetes mellitus, hypertension, ischemic heart disease, cerebral infarction, etc)
Patients who cannot understand or conform to the study protocol.
Patients who refuse to agree to the informed consent.
Patients with contraindication to aflibercept
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| Name | Affiliation | Role |
|---|---|---|
| Jae Pil Shin, MD, PhD | Kyungbuk National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busan Paik Hospital | Busanjin-gu | Busan | 614-735 | South Korea | ||
| Haeundae Paik Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17021319 | Background | Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655. | |
| 17021318 | Background | Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aflibercept | Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year). aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Percentage of Patients With Visual Acuity >=20/200 | Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 35 ETDRS letters (equivalent to 20/200) or better was calculated. | 12 months |
| Percentage of Patients With Visual Acuity >=20/40 | Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 70 ETDRS letters (equivalent to 20/40) or better was calculated. | 12 months |
| Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography | ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution. | 12 months |
| VFQ (Visual Function Questionaire)-25 Score | Quality of life was assessed using VFQ -25 score . The VFQ-25 includes 25 questions, and the total score ranges from 0 to 100. Higher scores represents better functioning. | 12 months |
| Haeundae |
| Busan |
| 612-030 |
| South Korea |
| Gospel Hospital | Seo-gu | Busan | 602-702 | South Korea |
| Pusan National University Hospital | Seo-gu | Busan | 602-739 | South Korea |
| Keimyung University Dongsan Medical Center | Jung-gu | Daegu | South Korea |
| Kyungpook National University Hospital | Jung-gu | Daegu | South Korea |
| Yeungnam University Medical Center | Nam-gu | Daegu | 705-717 | South Korea |
| Gyeongsang National University Hospital | Jinju | Gyeongsangnam-do | 660-702 | South Korea |
| 23084240 | Background | Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17. |
| 20719300 | Background | Stangos AN, Gandhi JS, Nair-Sahni J, Heimann H, Pournaras CJ, Harding SP. Polypoidal choroidal vasculopathy masquerading as neovascular age-related macular degeneration refractory to ranibizumab. Am J Ophthalmol. 2010 Nov;150(5):666-73. doi: 10.1016/j.ajo.2010.05.035. Epub 2010 Aug 16. |
| 22426346 | Background | Koh A, Lee WK, Chen LJ, Chen SJ, Hashad Y, Kim H, Lai TY, Pilz S, Ruamviboonsuk P, Tokaji E, Weisberger A, Lim TH. EVEREST study: efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy. Retina. 2012 Sep;32(8):1453-64. doi: 10.1097/IAE.0b013e31824f91e8. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aflibercept | Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year). aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe. |
| Units | Counts |
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| 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 | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Visual acuity | Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. ETDRS letters of 85 are equivalent to 20/20 of vision. | Mean | Standard Deviation | letters |
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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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Lose Visual Acuity Less Than 15 Letters | Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning. | Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set. | Posted | Number | percentage of patients | 12 months |
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| Secondary | Change in Visual Acuity From Baseline to 12 Months | Mean changes of visual acuity in ETDRS letters. Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. A change of 5 letters is equivalent to a 1-line change. | Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set. | Posted | Mean | Full Range | letters | Baseline and 12 months |
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| Secondary | Percentage of Patients With Visual Acuity >=20/200 | Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 35 ETDRS letters (equivalent to 20/200) or better was calculated. | Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set. | Posted | Number | percentage of patients | 12 months |
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| Secondary | Percentage of Patients With Visual Acuity >=20/40 | Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 70 ETDRS letters (equivalent to 20/40) or better was calculated. | Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set. | Posted | Number | percentage of patients | 12 months |
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| Secondary | Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography | ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution. | Among 45 patients who completed the study, data of 6 were inadequate for the analysis. 39 patients were included in the analysis. | Posted | Number | percentage of patients | 12 months |
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| Secondary | VFQ (Visual Function Questionaire)-25 Score | Quality of life was assessed using VFQ -25 score . The VFQ-25 includes 25 questions, and the total score ranges from 0 to 100. Higher scores represents better functioning. | Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set. | Posted | Mean | Inter-Quartile Range | scores on a scale | 12 months |
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Adverse events data was collected during the study perioid, or 1 year.
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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 | Aflibercept | Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year). aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe. Among 48 patients enrolled, one patient withdrew the consent before undergoing the first injection. Therefore the adverse event was assessed in 47 patients. | 1 | 47 | 4 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | SNOMED CT | Non-systematic Assessment | Death resulted from pneumonia. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hemorrhage | Eye disorders | SNOMED CT | Non-systematic Assessment |
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Conjunctival hemorrhage is assessed based on medical records, and the incidence might be underestimated.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ji Eun Lee, Assoicated professor | Pusan National University Hospital | +82-51-240-7957 | jlee@pusan.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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