Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO)

Retinal Vein Occlusion Clinical Trial

— JPMS-CRVO  

Official title:

Special Drug Use Investigation of EYLEA for CRVO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040220
• Other study ID #: 16641
• Secondary ID: EYL-CRVO
• Status: Completed
• Start date: January 24, 2014
• Est. completion date: November 9, 2018

Study information

• Verified date: April 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: November 9, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)		6 months after start of treatment with the drug
Secondary	Effectiveness (visual acuity)		6months after start of treatment with the drug
Secondary	Effectiveness (retina thickness)		6months after start of treatment with the drug

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