Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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. Identifier: NCT01824225
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : October 7, 2015
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT01824225

Layout table for location information
Surugadai Nihon university hospital
Chiyoda-ku, Tokyo, Japan, 101-8309
Sponsors and Collaborators
Nihon University
Layout table for investigator information
Study Chair: Mitsuko Yuzawa, M.D. Surugadai Nihon University Hospital

Layout table for additonal information
Responsible Party: Koji Tanaka, Lecturer, Nihon University 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:
intravitreal injection
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases