- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02425501
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.
The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. In total, 600 patients will be recruited.
For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Multiple Locations, Japan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who start EYLEA treatment for Diabetic Macular Edema (DME)
Exclusion Criteria:
- Patients who have already received EYLEA treatment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Aflibercept (Eylea,BAY86-5321)
Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert
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Administration by intravitreal injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants of Adverse Events
Time Frame: Up to 12 months
|
Up to 12 months
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Number of participants of Serious Adverse Events
Time Frame: Up to 12 months
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in visual acuity from baseline to 12 months
Time Frame: Baseline to 12 months
|
Baseline to 12 months
|
Mean change in retina thickness from baseline to 12 months
Time Frame: Baseline to 12 months
|
Baseline to 12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17544
- EY1510JP (Other Identifier: Company internal)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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