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Study of PRN and Every 2months Intravitreal Aflibercept for Age Related Macular Degeneration

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: NCT01824225
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Koji Tanaka, Nihon University

Brief Summary:
Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial monthly intravitreal aflibercept for the Japanese age related macular degeneration.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Drug: Aflibercept Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of PRN and Every 2months Intravitreal Aflibercept After 3 Initial Monthly Injection for Age Related Macular Degeneration
Study Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PRN injection of aflibercept
Intravitreal aflibercept
Drug: Aflibercept
Active Comparator: Two months injection of aflibercept
Intravitreal afilibercept
Drug: Aflibercept



Primary Outcome Measures :
  1. Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of age-related macular degeneration

Exclusion Criteria:

  • Any treatment before intravitreal Aflibercept for age-related macular degeneration.
  • Visual acuity above 0.1 in decimal visual acuity

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): NCT01824225


Locations
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Japan
Surugadai Nihon university hospital
Chiyoda-ku, Tokyo, Japan, 101-8309
Sponsors and Collaborators
Nihon University
Investigators
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Study Chair: Mitsuko Yuzawa, M.D. Surugadai Nihon University Hospital

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Responsible Party: Koji Tanaka, Lecturer, Nihon University
ClinicalTrials.gov Identifier: NCT01824225    
Other Study ID Numbers: NihonU-2
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Keywords provided by Koji Tanaka, Nihon University:
aflibercept
intravitreal injection
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases