Status:
COMPLETED
Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)
Lead Sponsor:
Bayer
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Adults ≥ 18 years with type 1 or 2 diabetes mellitus
- Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye
- BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye
Exclusion
- Active proliferative diabetic retinopathy (PDR) in the study eye
- Uncontrolled diabetes mellitus, as defined by HbA1c \>12%
- Only 1 functional eye even if that eye is otherwise eligible for the study
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01512966
Start Date
January 1 2012
End Date
September 1 2013
Last Update
October 9 2014
Active Locations (18)
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1
Matsuyama, Ehime, Japan, 790-8524
2
Maebashi, Gunma, Japan, 371-8511
3
Kobe, Hyōgo, Japan, 650-0017
4
Mito, Ibaraki, Japan, 310-0015