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 27, 2018
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|
|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|
Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)
Patients treated with EYLEA under practical manner for AMD.
- 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 ]
- 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 ]
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
|Multiple Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|