Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02425501
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 662
• Location: 1
• Actual Duration (Months): 54.7
• Patients Per Site Per Month: 12.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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).

Study Design

• 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: Jan 20, 2015
• Actual Primary Completion Date: Apr 26, 2019
• Actual Study Completion Date: Aug 13, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Number of participants of Adverse Events [Up to 12 months]

2. Number of participants of Serious Adverse Events [Up to 12 months]

Secondary Outcome Measures

1. Mean change in visual acuity from baseline to 12 months [Baseline to 12 months]

2. Mean change in retina thickness from baseline to 12 months [Baseline to 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who have already received EYLEA treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Multiple Locations		Japan

Sponsors and Collaborators

• Bayer
• Regeneron Pharmaceuticals

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02425501
• Other Study ID Numbers: 17544; EY1510JP
• First Posted: Apr 24, 2015
• Last Update Posted: Sep 13, 2019
• Last Verified: Sep 1, 2019

• 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: Macular Edema; Choroidal Neovascularization; Neovascularization, Pathologic; Aflibercept

Study Results

No Results Posted as of Sep 13, 2019