Polypoidal Choroidal Vasculopathy Clinical Trial
— VAULTOfficial title:
An Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Injection of VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
Verified date | December 2014 |
Source | Pusan National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy (PCV) will be evaluated.
Status | Active, not recruiting |
Enrollment | 48 |
Est. completion date | December 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 1. Visual acuity between 20/40 and 20/320 2. Active leakage in fluorescein angiography 3. Presence of any fluid in OCT(optical coherence tomography)-intraretinal, subretinal, sub-retinal pigment epithelial Exclusion Criteria: 1. Extramacular PCV 2. Subretinal hemorrhage or other retinal lesions blocking angiographic characteristics in more than 50% area of PCV lesion. 3. Previous treatment of intravitreal injections (anti-VEGF, steroid or other agents) 4. Previous treatment of photodynamic therapy 5. Previous ocular surgery except cataract surgery before 3 or more months 6. Presence of exudative AMD in the other eyes requiring anti-VEGF treatment (Intravitreal bevacizumab was reported to affect the other eye.) 7. Presence of other ocular diseases which may affect visual acuity (glaucoma, cataract with opacity involving visual axis, etc) 8. Presence of uncontrolled systemic disease (diabetes mellitus, hypertension, ischemic heart disease, cerebral infarction, etc) 9. Patients who cannot understand or conform to the study protocol. 10. Patients who refuse to agree to the informed consent. 11. Patients with contraindication to aflibercept - Ocular or periocular infection - Active severe intraocular inflammation - Known hypersensitivity to aflibercept or to any of the excipients |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Busan Paik Hospital | Busanjin-gu | Busan |
Korea, Republic of | Haeundae Paik Hospital | Haeundae | Busan |
Korea, Republic of | Gyeongsang National University Hospital | Jinju | Gyeongsangnam-do |
Korea, Republic of | Keimyung University Dongsan Medical Center | Jung-gu | Daegu |
Korea, Republic of | Kyungpook National University Hospital | Jung-gu | Daegu |
Korea, Republic of | Yeungnam University Medical Center | Nam-gu | Daegu |
Korea, Republic of | Gospel Hospital | Seo-gu | Busan |
Korea, Republic of | Pusan National University Hospital | Seo-gu | Busan |
Lead Sponsor | Collaborator |
---|---|
Pusan National University Hospital | Bayer |
Korea, Republic of,
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. — View Citation
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. Erratum in: Ophthalmology. 2013 Jan;120(1):209-10. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual acuity reservation | Proportion of patients lose visual acuity less than 3 lines or 15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters | 12 months | No |
Secondary | Visual acuity changes | Mean changes of visual acuity in ETDRS letters | 12 months | No |
Secondary | Visual acuity >20/200 | Proportion of patients having visual acuity more than 20/200 | 12 months | No |
Secondary | Visual acuity >20/40 | Proportion of patients having visual acuity more than 20/40 | 12 months | No |
Secondary | ICG angiography | Proportion of patients having complete resolution of polypoidal lesion in ICG angiography | 12 months | No |
Secondary | Quality of Life | VFQ (visual function questionaire)-25 score | 12 months | No |
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