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

NCT01756248 | Completed

• 2 other identifiers: 15895EYL-AMD
• Study Type: observational
• Target: 3,872
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Keywords

EYLEA; Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA

  Up to 3 years

• 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 Outcomes (5)

• 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

• Mean changes in visual acuity

  Baseline and 6, 24 or 36 months

• 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

• Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments

  Baseline and 6, 24 or 36 months

• Number and intervals of ITV injection of EYLEA

  Up to 3 years

Study Arms (1)

Group 1

Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)

Interventions

Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321) DRUG

Patients treated with EYLEA under practical manner for AMD.

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with subfovear choroidal neovascular age-related macular degeneration

You may qualify if:

• Patients who received EYLEA for AMD

You may not qualify if:

• Patients who have already received EYLEA

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (1)

• Ozawa Y, Ohgami K, Sasaki K, Hirano K, Sunaya T. Long-term surveillance provides real-world evidences of safety and effectiveness in intravitreal aflibercept treatment for age-related macular degeneration. Sci Rep. 2023 Jun 30;13(1):10597. doi: 10.1038/s41598-023-37584-1.

  PMID: 37391547 DERIVED

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 25, 2012
• Study Start: December 26, 2012
• Primary Completion: December 31, 2018
• Study Completion: May 20, 2019
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

JP (1)