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Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

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: NCT02425501
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Brief Summary:
The objectives of this study are to investigate the safety and effectiveness of EYLEA

Condition or disease Intervention/treatment
Choroidal Neovascularization Drug: Aflibercept (Eylea, BAY86-5321)

Detailed Description:

This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. 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. In total, 600 patients will be recruited.

For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).


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Study Type : Observational
Actual Enrollment : 662 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
Actual Study Start Date : January 20, 2015
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : August 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort Intervention/treatment
Aflibercept (Eylea,BAY86-5321)
Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert
Drug: Aflibercept (Eylea, BAY86-5321)
Administration by intravitreal injection




Primary Outcome Measures :
  1. Number of participants of Adverse Events [ Time Frame: Up to 12 months ]
  2. Number of participants of Serious Adverse Events [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Mean change in visual acuity from baseline to 12 months [ Time Frame: Baseline to 12 months ]
  2. Mean change in retina thickness from baseline to 12 months [ Time Frame: Baseline to 12 months ]


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 DME diagnosis will be enrolled after the investigators have taken the decision for the treatment with EYLEA. Those patients who have had EYLEA prescribed previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and be familiarized with the safety information in the product package label.
Criteria

Inclusion Criteria:

  • Patients who start EYLEA treatment for Diabetic Macular Edema (DME)

Exclusion Criteria:

  • Patients who have already received EYLEA treatment

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): NCT02425501


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: NCT02425501     History of Changes
Other Study ID Numbers: 17544
EY1510JP ( Other Identifier: Company internal )
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 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:
Aflibercept
anti-VEGF
Additional relevant MeSH terms:
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Macular Edema
Choroidal Neovascularization
Neovascularization, Pathologic
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases