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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02040220
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Brief 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 )


Condition or disease Intervention/treatment
Retinal Vein Occlusion Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

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Study Type : Observational
Actual Enrollment : 385 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Effectiveness (visual acuity) [ Time Frame: 6months after start of treatment with the drug ]
  2. Effectiveness (retina thickness) [ Time Frame: 6months after start of treatment with the drug ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female and male patients with a diagnosis of CRVO will be enrolled after the decision for treatment with EYLEA has been made by the investigator. Those patients prescribed EYLEA previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and familiarize themselves with the safety information in the product package label. Eligible patients who receive EYLEA will be enrolled and documented in the eCRF.
Criteria

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

Information from the National Library of Medicine

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


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02040220     History of Changes
Other Study ID Numbers: 16641
EYL-CRVO ( Other Identifier: company internal )
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
CRVO, Macular edema, Aflibercept, anti-VEGF
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases