Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)
Phase 3
Completed
- Conditions
- Macular Edema
- Registration Number
- NCT01512966
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse Event collection Week 52
- Secondary Outcome Measures
Name Time Method Change from baseline in BCVA (best corrected visual acuity) letter score Week 52