check_circleStudy Completed

Retinal Vein Occlusion

Bayer Identifier:

18586

ClinicalTrials.gov Identifier:

NCT02645747

EudraCT Number:

Not Available

EU CT Number:

Not Available
Retrospective data analysis of patients treated for Macular Edema due to Central Retinal Vein Occlusion

Trial purpose

The objective of this retrospective chart review is to evaluate drug utilization, usage patterns and indication of effectiveness Eylea in the routine clinical (real-life) management of patients who suffer from ME (Macular Edema), secondary to CRVO (Central Retinal Vein Occlusion), and who started treatment with Eylea for this indication.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Male or female adult patients who suffer from visual impairment due to ME secondary to CRVO
    - Anti-VEGF treatment-naive patients who started reimbursed Eylea treatment between the 1st of June 2014 and the 28th of February 2015
  • - Patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.

Trial summary

Enrollment Goal
126
Trial Dates
January 2016 - December 2017
Phase
N/A
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Belgium

Primary Outcome

  • Treatment duration
    date_rangeTime Frame:
    At 12 months of treatment with Eylea
    enhanced_encryption
    Safety Issue:
    No
  • Number of eyes treated (mono-and biocular)
    date_rangeTime Frame:
    At 12 months of treatment with Eylea
    enhanced_encryption
    Safety Issue:
    No
  • Change in visual acuity (BCVA score)
    date_rangeTime Frame:
    At 12 months of treatment with Eylea
    enhanced_encryption
    Safety Issue:
    No
  • Number of Eylea injections per treated eye
    date_rangeTime Frame:
    At 12 months of treatment with Eylea
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Estimation of percentage (%) of eyes which need additional treatment after 2 years at the discretion of the treating physician.
    date_rangeTime Frame:
    At 12 months of treatment with Eylea
    enhanced_encryption
    Safety Issue:
    No
  • Sufficiency of reimbursed number of Eylea injections (max. 9 injections/eye in year 1) for treatment of all patients during the first year of treatment.
    date_rangeTime Frame:
    At 12 months of treatment with Eylea
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients who discontinued their treatment with Eylea prematurely
    Investigator is asked to categorize the number of patients who ended their treatment prematurely according to the following reasons : - Lost-to-follow up (measured as number of patients) - Lack of efficacy (measured as number of patients) - Remission (measured as number of patients) - AE (measured as number of patients) - Other (measured as number of patients)
    date_rangeTime Frame:
    At 12 months of treatment with Eylea
    enhanced_encryption
    Safety Issue:
    No

Trial design

RETRO CRVO: Retrospective data analysis of patients treated for Macular Edema due to Central Retinal Vein Occlusion
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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