check_circleStudy Completed
Retinal Vein Occlusion
Bayer Identifier:
16641
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Prospective, non-interventional, multi-center post-authorization safety study of Eylea for central retinal vein occlusion (CRVO)
Trial purpose
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 )
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 )
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
385Trial Dates
January 2014 - November 2018Phase
N/ACould I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)date_rangeTime Frame:6 months after start of treatment with the drugenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Effectiveness (visual acuity)date_rangeTime Frame:6months after start of treatment with the drugenhanced_encryptionNoSafety Issue:
- Effectiveness (retina thickness)date_rangeTime Frame:6months after start of treatment with the drugenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A