Trial Condition(s):
Retinal Vein Occlusion
Prospective, non-interventional, multi-center post-authorization safety study of Eylea for central retinal vein occlusion (CRVO) (JPMS-CRVO)
Bayer Identifier:
16641
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 )
Inclusion Criteria
- Patients who start EYLEA treatment for CRVO
Exclusion Criteria
- Patients who have already received EYLEA treatment - Patients who are contraindicated based on approved label
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Special Drug Use Investigation of EYLEA for CRVO
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)Timeframe: 6 months after start of treatment with the drug
Secondary Outcome
- Effectiveness (visual acuity)Timeframe: 6months after start of treatment with the drug
- Effectiveness (retina thickness)Timeframe: 6months after start of treatment with the drug
Additional Information
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