check_circleStudy Completed
Wet age-related macular degeneration
Bayer Identifier:
16623
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Investigating the effectiveness of Eylea in patients with wet age-related macular degeneration
Trial purpose
The study aims to investigate the effectiveness of Eylea in patients with wet age-related macular degeneration in routine clinical practice in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.
Key Participants Requirements
Sex
BothAge
0 - N/ATrial summary
Enrollment Goal
988Trial Dates
July 2013 - March 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, Germany |
Primary Outcome
- Mean change of visual acuity for the total patient populationdate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean change of visual acuity for the subgroup of pretreated patientsdate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean change of visual acuity for the subgroup of non-pretreated patientsdate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Monitoring of disease activityMonitoring of disease activity in routine clinical practice setting will be assessed e.g. by determining the o No. of clinical visits (visits for injections) o No. of monitoring visits (visits only for diagnostic purposes, but without injections) o No. of safety visits after the injection (visits only for safety checks after injection) o No. of visits outside the study center o No. of OCT (optical coherence tomography) assessments per patient after 12 and 24 monthsdate_rangeTime Frame:after 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Monitoring of treatment patternssame assessment as indicated for "Monitoring of disease activity"date_rangeTime Frame:after 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean time from indication of Eylea-treatment by the treating physician to start of treatmentdate_rangeTime Frame:after 12 and 24 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A