EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01756248
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 4,017
• Location: 1
• Actual Duration (Months): 76.7
• Patients Per Site Per Month: 52.3

Study Details

Study Description

Brief Summary

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD).

The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice.

A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)

Study Design

• Study Type: Observational
• Actual Enrollment: 4017 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Special Drug Use Investigation of EYLEA for AMD
• Actual Study Start Date: Dec 26, 2012
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: May 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321); Patients treated with EYLEA under practical manner for AMD.

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA [Up to 3 years]

2. Number of participants with serious adverse events (SAEs) and ocular adverse events(AEs) (especially AEs due to ITV injection procedure) from the first ITV injection of EYLEA [Up to 3 years]

Secondary Outcome Measures

1. Number of participants with ADRs, SAEs and ocular AEs ( especially AEs due to ITV injection procedure) in subpopulations of patients background characteristics and status of EYLEA treatments from the first ITV injection of EYLEA [Up to 3 years]

2. Mean changes in visual acuity [Baseline and 6, 24 or 36 months]

3. Proportion of patients who maintained visual acuity(corresponding to <15 letters of Early Treatment Diabetic Retinopathy Study(ETDRS) from baseline) and improved visual acuity(corresponding to >0 letter of ETDRS from baseline) [Up to 3 years]

4. Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments [Baseline and 6, 24 or 36 months]

5. Number and intervals of ITV injection of EYLEA [Up to 3 years]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients who received EYLEA for AMD

Exclusion Criteria:

• Patients who have already received EYLEA

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: NCT01756248
• Other Study ID Numbers: 15895; EYL-AMD
• First Posted: Dec 25, 2012
• Last Update Posted: Jun 25, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by Bayer: EYLEA; Age-Related Macular Degeneration
• Additional relevant MeSH terms: Macular Degeneration; Aflibercept

Study Results

No Results Posted as of Jun 25, 2019