Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization
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|ClinicalTrials.gov Identifier: NCT02260687|
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment|
|Choroidal Neovascularization||Drug: Aflibercept (Eylea, VEGF Trap-Eye, 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 1 years or until it is no longer possible (e.g. lost to follow-up within the 1 year ). In total, 300 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 :||353 participants|
|Official Title:||Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization|
|Actual Study Start Date :||December 5, 2014|
|Actual Primary Completion Date :||April 2, 2018|
|Actual Study Completion Date :||August 22, 2018|
Decision of treatment is made by attending investigator according to the Japanese Package Insert
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection
- Number of episodes of Adverse drug reaction (ADR's) [ Time Frame: Up to 12 months ]
- Number of episodes of Infections [ Time Frame: Up to 12 months ]
- Number of episodes of Serious Adverse Events(SAE's) [ Time Frame: Up to 12 months ]
- Number of episodes of Ocular Adverse events [ Time Frame: Up to 12 months ]
- Mean changes in visual acuity [ Time Frame: Baseline up to 12 months ]
- Mean changes in retina thickness [ Time Frame: Baseline up 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): NCT02260687
|Multiple Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|