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Exudative Age-related Macular DegenerationPhase 4VAULTNCT01950741

Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

A Phase 4 study testing aflibercept in people with Exudative Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy, run by Pusan National University Hospital at 8 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Any age
What is being tested?
aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
8 sitesSouth Korea
Study dates
Sep 2013to Aug 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)
Show all 14Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Korea8 sites

  • Busan Paik Hospital

    Busanjin-gu, Busan, 614-735

  • Haeundae Paik Hospital

    Haeundae, Busan, 612-030

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do, 660-702

  • Keimyung University Dongsan Medical Center

    Jung-gu, Daegu

  • Kyungpook National University Hospital

    Jung-gu, Daegu

  • Yeungnam University Medical Center

    Nam-gu, Daegu, 705-717

  • Gospel Hospital

    Seo-gu, Busan, 602-702

  • Pusan National University Hospital

    Seo-gu, Busan, 602-739

Other trials in South Korea

About this study

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

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

Read the 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.

Being tested
aflibercept
Medical subject headings
Polypoidal Choroidal Vasculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • afliberceptDrug

    Also called Eyelea, VEGF Trap-Eye

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

Study groups in NCT01950741
Study groupRoleWhat they receive
afliberceptExperimentalAflibercept 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).
Receives: Drug: aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (5)

  1. 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.

    Measured: Baseline and 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01950741
Sponsor's protocol ID
D-1304-013-014
Acronym
VAULT
Status last verified
Mar 2016
First submitted
23 Sep 2013
Last updated
29 Apr 2016
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17021319

  • 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.

    PubMed 17021318

  • 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.

    PubMed 23084240

  • 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.

    PubMed 20719300

  • 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.

    PubMed 22426346

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing aflibercept in people with Exudative Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy, run by Pusan National University Hospital at 8 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Lose Visual Acuity Less Than 15 Letters (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01950741, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.

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