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

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: NCT01756248
Recruitment Status : Completed
First Posted : December 25, 2012
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date December 20, 2012
First Posted Date December 25, 2012
Last Update Posted Date June 25, 2019
Actual Study Start Date December 26, 2012
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2012)
  • Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA [ Time Frame: 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 [ Time Frame: Up to 3 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01756248 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 20, 2012)
  • 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 [ Time Frame: Up to 3 years ]
  • Mean changes in visual acuity [ Time Frame: 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) [ Time Frame: Up to 3 years ]
  • Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments [ Time Frame: Baseline and 6, 24 or 36 months ]
  • Number and intervals of ITV injection of EYLEA [ Time Frame: Up to 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan
Official Title Special Drug Use Investigation of EYLEA for AMD
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with subfovear choroidal neovascular age-related macular degeneration
Condition Macular Degeneration
Intervention Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)
Patients treated with EYLEA under practical manner for AMD.
Study Groups/Cohorts Group 1
Intervention: Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 8, 2016)
4017
Original Estimated Enrollment
 (submitted: December 20, 2012)
4000
Actual Study Completion Date May 20, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who received EYLEA for AMD

Exclusion Criteria:

  • Patients who have already received EYLEA
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01756248
Other Study ID Numbers 15895
EYL-AMD ( Other Identifier: company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date June 2019