Trial Condition(s):
Macular Edema
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
Bayer Identifier:
17544
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The objectives of this study are to investigate the safety and effectiveness of EYLEA
Inclusion Criteria
- Patients who start EYLEA treatment for Diabetic Macular Edema (DME)
Exclusion Criteria
- Patients who have already received EYLEA treatment
Trial Summary
Enrollment Goal
646
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants of Adverse EventsTimeframe: Up to 12 months
- Number of participants of Serious Adverse EventsTimeframe: Up to 12 months
Secondary Outcome
- Mean change in visual acuity from baseline to 12 monthsTimeframe: Baseline to 12 months
- Mean change in retina thickness from baseline to 12 monthsTimeframe: Baseline to 12 months
Additional Information
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