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Efficacy and Safety of Intravitreal Vascular Endothelial Growth Factor Trap-eye in Patients With Polyploidal Choroidal Vasculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02072408
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Kim's Eye Hospital
Bayer
Information provided by (Responsible Party):
Samsung Medical Center

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.

Condition or disease Intervention/treatment Phase
Polypoidal Choroidal Vasculopathy Without Active Polyp Drug: aflibercept Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2014
Actual Primary Completion Date : November 2, 2017
Actual Study Completion Date : November 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: polypoidal choroidal vasculopathy without polyp Drug: aflibercept
  1. Three monthly intravitreal aflibercept (2mg) injections
  2. Five bimonthly intravitreal aflibercept (2mg) injections
  3. Rescue treatment: Verteporfin photodynamic therapy

    • Loss of five ETDRS letters or one Snellen line of vision from baseline
    • Presence of subretinal fluid or intraretinal fluid despite three consecutive (monthly or bimonthly) aflibercept injection
    • Presence of active polyp on indocyanine green angiography




Primary Outcome Measures :
  1. Change of best-corrected visual acuity (ETDRS letters) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. presence of subretinal hemorrhage [ Time Frame: during 1 year ]
    Total number of months when subretinal hemorrhage are detected on fundus photographs.

  2. presence of fluid in macula evidenced by optical coherence tomography [ Time Frame: during 1 year ]
    Total number of months when fluid in macula are detected on optical coherence tomography

  3. change of indocyanine green angiography [ Time Frame: during 1 year ]

    Change of indocyanine green angiography will include followings

    1. New appearance of polypoidal structure
    2. Any change in size of the greatest linear dimension of lesion
    3. Any change in size and activity of branching vascular network

  4. Number of eyes which need rescue treatment (photodynamic therapy) [ Time Frame: during 1 year ]
    In this study, photodynamic therapy will be performed as a rescue therapy according to the necessary criteria.

  5. safety outcomes [ Time Frame: one year ]
    frequency and severity of ocular adverse event



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • polypoidal choroidal vasculopathy without active polyp
  • decreased visual acuity by subretinal fluid and hemorrhage involving foveal center

Exclusion Criteria:

  • polypoidal choroidal vasculopathy with active polyp
  • previous photodynamic therapy more than three times
  • anti-VEGF injection within one month
  • photodynamic therapy or intraocular steroid treatment within three months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072408


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, Korea, Republic of
Konyang University Kim's Eye Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Seoul National University Bundang Hospital
Kim's Eye Hospital
Bayer

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02072408    
Other Study ID Numbers: 2013-10-044-002
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: February 2014
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases