Trial Condition(s):
Retinal Vein Occlusion
Retrospective data analysis of patients treated for Macular Edema due to Central Retinal Vein Occlusion (RETRO CRVO)
Bayer Identifier:
18586
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
Exclusion Criteria
- Patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Belgium | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
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:
1
Primary Outcome
- Treatment durationTimeframe: At 12 months of treatment with Eylea
- Number of eyes treated (mono-and biocular)Timeframe: At 12 months of treatment with Eylea
- Change in visual acuity (BCVA score)Timeframe: At 12 months of treatment with Eylea
- Number of Eylea injections per treated eyeTimeframe: At 12 months of treatment with Eylea
Secondary Outcome
- Estimation of percentage (%) of eyes which need additional treatment after 2 years at the discretion of the treating physician.Timeframe: At 12 months of treatment with Eylea
- 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.Timeframe: At 12 months of treatment with Eylea
- Number of patients who discontinued their treatment with Eylea prematurelyInvestigator 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)Timeframe: At 12 months of treatment with Eylea
Additional Information
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