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Trial record 41 of 122 for:    regeneron AND VEGF Trap-Eye

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

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ClinicalTrials.gov Identifier: NCT01756248
Recruitment Status : Active, not recruiting
First Posted : December 25, 2012
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

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

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 : December 26, 2012
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 3 years ]
  2. Mean changes in visual acuity [ Time Frame: 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) [ Time Frame: Up to 3 years ]
  4. 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 ]
  5. Number and intervals of ITV injection of EYLEA [ Time Frame: Up to 3 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with subfovear choroidal neovascular age-related macular degeneration
Criteria

Inclusion Criteria:

  • Patients who received EYLEA for AMD

Exclusion Criteria:

  • Patients who have already received EYLEA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756248


Locations
Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01756248     History of Changes
Other Study ID Numbers: 15895
EYL-AMD ( Other Identifier: company internal )
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

Keywords provided by Bayer:
EYLEA
Age-Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases