check_circleStudy Completed
Macular Edema
Bayer Identifier:
15657
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Japanese safety study of VEGF Trap-Eye in DME (diabetic macular edema)
Trial purpose
This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
73Trial Dates
January 2012 - September 2013Phase
Phase 3Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Gunma University Hospital | Maebashi, 371-8511, Japan |
Completed | Shiga University of Medical Science Hospital | Otsu, 520-2192, Japan |
Completed | Kyoto University Hospital | Kyoto, 606-8507, Japan |
Completed | Osaka University Hospital | Suita, 565-0871, Japan |
Completed | Kagawa University Hospital | Kita, 761-0793, Japan |
Completed | Kagoshima University Medical and Dental Hospital | Kagoshima, 890-8520, Japan |
Terminated | Nishi Eye Hospital | Osaka, 537-0025, Japan |
Completed | Matsuyama Red Cross Hospital | Matsuyama, 790-8524, Japan |
Completed | Nara Medical University Hospital | Kashihara, 634-8522, Japan |
Completed | Osaka General Medical Center | Osaka, 558-8558, Japan |
Completed | Saga-Ken Medical Centre Koseikan | Saga, 840-8571, Japan |
Completed | Jichi Medical University Hospital | Shimotsuke, 329-0498, Japan |
Completed | Mito Kyodo General Hospital | Mito, 310-0015, Japan |
Completed | Kobe University Hospital | Kobe, 650-0017, Japan |
Completed | Okayama University Hospital | Okayama, 700-8558, Japan |
Completed | NTT East Japan Tohoku Hospital | Sendai, 984-8560, Japan |
Completed | Wakayama Medical University Hospital | Wakayama, 641-8510, Japan |
Completed | St. Marianna University of School Medicine Hospital | Kawasaki, 216-8511, Japan |
Primary Outcome
- Adverse Event collectiondate_rangeTime Frame:Week 52enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Change from baseline in BCVA (best corrected visual acuity) letter scoredate_rangeTime Frame:Week 52enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
Biological/VaccineTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1