Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

Polypoidal Choroidal Vasculopathy Clinical Trial

— VAULT  

Official title:

An Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Injection of VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01950741
• Other study ID #: D-1304-013-014
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 23, 2013
• Last updated: December 17, 2014
• Start date: September 2013
• Est. completion date: December 2015

Study information

• 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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exudative Age-related Macular Degeneration
• Macular Degeneration
• Polypoidal Choroidal Vasculopathy
• Vascular Diseases
• Wet Macular Degeneration

Intervention

Drug:
• aflibercept
Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Pusan National University Hospital	Bayer

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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

Outcome

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