check_circleStudy Completed
Macular Edema
Bayer Identifier:
17544
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
Trial purpose
The objectives of this study are to investigate the safety and effectiveness of EYLEA
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
646Trial Dates
January 2015 - August 2019Phase
Phase 4Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Number of participants of Adverse Eventsdate_rangeTime Frame:Up to 12 monthsenhanced_encryptionYesSafety Issue:
- Number of participants of Serious Adverse Eventsdate_rangeTime Frame:Up to 12 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Mean change in visual acuity from baseline to 12 monthsdate_rangeTime Frame:Baseline to 12 monthsenhanced_encryptionNoSafety Issue:
- Mean change in retina thickness from baseline to 12 monthsdate_rangeTime Frame:Baseline to 12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A