- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01824225
Study of PRN and Every 2months Intravitreal Aflibercept for Age Related Macular Degeneration
October 5, 2015 updated by: Koji Tanaka, Nihon University
Study of PRN and Every 2months Intravitreal Aflibercept After 3 Initial Monthly Injection for Age Related Macular Degeneration
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Chiyoda-ku, Tokyo, Japan, 101-8309
- Surugadai Nihon university hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PRN injection of aflibercept
Intravitreal aflibercept
|
|
Active Comparator: Two months injection of aflibercept
Intravitreal afilibercept
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mitsuko Yuzawa, M.D., Surugadai Nihon university hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
March 31, 2013
First Submitted That Met QC Criteria
April 3, 2013
First Posted (Estimate)
April 4, 2013
Study Record Updates
Last Update Posted (Estimate)
October 7, 2015
Last Update Submitted That Met QC Criteria
October 5, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NihonU-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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