Eylea Regulatory Post Marketing Surveillance(rPMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bayer
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01783925
First received: February 1, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eylea Regulatory Post Marketing Surveillance in Korea

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart.[BCVA: Best Corrected Visual Acuity] [ Time Frame: 4 months or 8 months ] [ Designated as safety issue: No ]
  • Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography] [ Time Frame: 4 months or 8 months ] [ Designated as safety issue: No ]
  • Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography [ Time Frame: 4 months or 8 months ] [ Designated as safety issue: No ]
  • IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure] [ Time Frame: 4 months or 8 months ] [ Designated as safety issue: No ]
  • Measurement of fundus lesion by fundoscopy [ Time Frame: 4 months or 8 months ] [ Designated as safety issue: No ]
  • Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3600
Study Start Date: April 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with wet age-related macular degeneration(wAMD) who are decided to receive EYLEA (VEGF Trap Eye) treatment

Criteria

Inclusion Criteria:

  • Patients determined to start EYLEA treatment
  • Patients who are prescribed with anti-VEGF therapy for the first time

Exclusion Criteria:

  • Patients who previously received anti-VEGF therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783925

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Korea, Republic of
Recruiting
Many Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01783925     History of Changes
Other Study ID Numbers: 16469, EY1310KR
Study First Received: February 1, 2013
Last Updated: September 25, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on September 30, 2014