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NCT02425501 Clinical Trial

Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

Macular Edema Clinical Trial

Official title:
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02425501
Other study ID # 17544
Secondary ID EY1510JP
Status Completed
Phase
First received
Last updated
Start date January 20, 2015
Est. completion date August 13, 2019

Study information
Verified date January 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 646
Est. completion date August 13, 2019
Est. primary completion date April 26, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who start EYLEA treatment for Diabetic Macular Edema (DME) Exclusion Criteria: - Patients who have already received EYLEA treatment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aflibercept (Eylea, BAY86-5321)
Administration by intravitreal injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants of Adverse Events Up to 12 months
Primary Number of participants of Serious Adverse Events Up to 12 months
Secondary Mean change in visual acuity from baseline to 12 months Baseline to 12 months
Secondary Mean change in retina thickness from baseline to 12 months Baseline to 12 months
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