Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO) (JPMS-CRVO)
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|ClinicalTrials.gov Identifier: NCT02040220|
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : April 10, 2019
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. 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.
For each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).
There will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )
|Condition or disease||Intervention/treatment|
|Retinal Vein Occlusion||Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|
|Study Type :||Observational|
|Actual Enrollment :||385 participants|
|Official Title:||Special Drug Use Investigation of EYLEA for CRVO|
|Actual Study Start Date :||January 24, 2014|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||November 9, 2018|
Eylea treatment goup
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
2 mg of Eylea will be treated per one injection at more than one months interval usually.
- Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular) [ Time Frame: 6 months after start of treatment with the drug ]
- Effectiveness (visual acuity) [ Time Frame: 6months after start of treatment with the drug ]
- Effectiveness (retina thickness) [ Time Frame: 6months after start of treatment with the drug ]
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): NCT02040220
|Multiple Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|