check_circleStudy Completed
Retinal Vein Occlusion
Bayer Identifier:
18586
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
126Trial Dates
January 2016 - December 2017Phase
N/ACould I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Belgium |
Primary Outcome
- Treatment durationdate_rangeTime Frame:At 12 months of treatment with Eyleaenhanced_encryptionNoSafety Issue:
- Number of eyes treated (mono-and biocular)date_rangeTime Frame:At 12 months of treatment with Eyleaenhanced_encryptionNoSafety Issue:
- Change in visual acuity (BCVA score)date_rangeTime Frame:At 12 months of treatment with Eyleaenhanced_encryptionNoSafety Issue:
- Number of Eylea injections per treated eyedate_rangeTime Frame:At 12 months of treatment with Eyleaenhanced_encryptionNoSafety Issue:
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 Eyleaenhanced_encryptionNoSafety Issue:
- 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 Eyleaenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:At 12 months of treatment with Eyleaenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A