Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

NCT01950741 | Completed Phase 4 Results

• 1 other identifier: D-1304-013-014
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Exudative Age-related Macular Degeneration; Polypoidal Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in Visual Acuity From Baseline to 12 Months

  Baseline and 12 months

• Percentage of Patients With Visual Acuity >=20/200

  12 months

• Percentage of Patients With Visual Acuity >=20/40

  12 months

• Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography

  12 months

• VFQ (Visual Function Questionaire)-25 Score

  12 months

Study Arms (1)

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).

Drug: aflibercept

Interventions

aflibercept DRUG

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

Also known as: Eyelea, VEGF Trap-Eye

aflibercept

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Visual acuity between 20/40 and 20/320
• Active leakage in fluorescein angiography
• Presence of any fluid in OCT(optical coherence tomography)-intraretinal, subretinal, sub-retinal pigment epithelial

You may not qualify if:

• 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
• Ocular or periocular infection
• Active severe intraocular inflammation
• Known hypersensitivity to aflibercept or to any of the excipients

Sponsors & Collaborators

• Pusan National University Hospital: lead
• Bayer: collaborator

Study Sites (8)

Busan Paik Hospital

Busanjin-gu, Busan, 614-735, South Korea

Location

Haeundae Paik Hospital

Haeundae, Busan, 612-030, South Korea

Location

Gospel Hospital

Seo-gu, Busan, 602-702, South Korea

Location

Pusan National University Hospital

Seo-gu, Busan, 602-739, South Korea

Location

Keimyung University Dongsan Medical Center

Jung-gu, Daegu, South Korea

Location

Kyungpook National University Hospital

Jung-gu, Daegu, South Korea

Location

Yeungnam University Medical Center

Nam-gu, Daegu, 705-717, South Korea

Location

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, 660-702, South Korea

Location

Related 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. doi: 10.1056/NEJMoa062655.

  PMID: 17021319 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.

  PMID: 17021318 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.

  PMID: 23084240 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.

  PMID: 20719300 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.

  PMID: 22426346 BACKGROUND

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Conjunctival hemorrhage is assessed based on medical records, and the incidence might be underestimated.

Results Point of Contact

• Title: Ji Eun Lee, Assoicated professor
• Organization: Pusan National University Hospital

jlee@pusan.ac.kr

+82-51-240-7957

Study Officials

• Jae Pil Shin, MD, PhD

  Kyungbuk National University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 25, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 29, 2016
• Results First Posted: April 29, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)