Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
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|ClinicalTrials.gov Identifier: NCT02425501|
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment|
|Choroidal Neovascularization||Drug: Aflibercept (Eylea, BAY86-5321)|
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 :||Observational|
|Actual Enrollment :||662 participants|
|Official Title:||Special Drug Use Investigation of EYLEA for Diabetic Macular Edema|
|Actual Study Start Date :||January 20, 2015|
|Actual Primary Completion Date :||April 26, 2019|
|Actual Study Completion Date :||August 13, 2019|
Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert
Drug: Aflibercept (Eylea, BAY86-5321)
Administration by intravitreal injection
- Number of participants of Adverse Events [ Time Frame: Up to 12 months ]
- Number of participants of Serious Adverse Events [ Time Frame: Up to 12 months ]
- Mean change in visual acuity from baseline to 12 months [ Time Frame: Baseline to 12 months ]
- Mean change in retina thickness from baseline to 12 months [ Time Frame: Baseline to 12 months ]
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): NCT02425501
|Multiple Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|