Back to resultsStudy of PRN and Every 2months Intravitreal Aflibercept for Age Related Macular Degeneration
Primary Purpose
Age-related Macular Degeneration
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring aflibercept, intravitreal injection
Eligibility 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
Sites / Locations
- Surugadai Nihon university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PRN injection of aflibercept
Two months injection of aflibercept
Arm Description
Intravitreal aflibercept
Intravitreal afilibercept
Outcomes
Primary Outcome Measures
Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01824225
Brief Title
Study of PRN and Every 2months Intravitreal Aflibercept for Age Related Macular Degeneration
Official Title
Study of PRN and Every 2months Intravitreal Aflibercept After 3 Initial Monthly Injection for Age Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nihon University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
aflibercept, intravitreal injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRN injection of aflibercept
Arm Type
Active Comparator
Arm Description
Intravitreal aflibercept
Arm Title
Two months injection of aflibercept
Arm Type
Active Comparator
Arm Description
Intravitreal afilibercept
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Primary Outcome Measure Information:
Title
Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsuko Yuzawa, M.D.
Organizational Affiliation
Surugadai Nihon University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Surugadai Nihon university hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study of PRN and Every 2months Intravitreal Aflibercept for Age Related Macular Degeneration
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