Clinical trial NCT01950741: Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
Official title: An Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Injection of VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Exudative Age-related Macular Degeneration
Polypoidal Choroidal Vasculopathy
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2013-09-25
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy (PCV) will be evaluated.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Lose Visual Acuity Less Than 15 Letters
timeFrame: 12 months
Secondary outcomes:
measure: Change in Visual Acuity From Baseline to 12 Months
timeFrame: Baseline and 12 months
measure: Percentage of Patients With Visual Acuity >=20/200
timeFrame: 12 months
measure: Percentage of Patients With Visual Acuity >=20/40
timeFrame: 12 months
measure: Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography
timeFrame: 12 months
measure: VFQ (Visual Function Questionaire)-25 Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Busanjin-gu
country: Korea, Republic of
facility: Busan Paik Hospital
state: Busan
city: Haeundae
country: Korea, Republic of
facility: Haeundae Paik Hospital
state: Busan
city: Seo-gu
country: Korea, Republic of
facility: Gospel Hospital
state: Busan
city: Seo-gu
country: Korea, Republic of
facility: Pusan National University Hospital
state: Busan
city: Jung-gu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
state: Daegu
city: Jung-gu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Daegu
city: Nam-gu
country: Korea, Republic of
facility: Yeungnam University Medical Center
state: Daegu
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsangnam-do
Study officials:
affiliation: Kyungbuk National University Hospital
name: Jae Pil Shin, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1056/NEJMoa054481.
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.
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.
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. doi: 10.1097/IAE.0b013e31824f91e8.