Extension Study of MYL-1701P-3001 for Safety and Efficacy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Macular Edema
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Diabetic retinopathy is an important cause of blindness worldwide. The International Diabetes Federation estimates that 285 million people worldwide have diabetes mellitus and approximately 7% of these individuals are affected by diabetic macular edema. EYLEA® (aflibercept) injection, an anti-Vascul...
Diabetic retinopathy is an important cause of blindness worldwide. The International Diabetes Federation estimates that 285 million people worldwide have diabetes mellitus and approximately 7% of these individuals are affected by diabetic macular edema. EYLEA® (aflibercept) injection, an anti-Vascular Endothelial Growth Factor (VEGF) agent, has been approved by the FDA and EMA for the treatment of Diabetic Macular Edema (DME). Mylan Inc. and Momenta Pharmaceuticals, Inc. are developing MYL-1701P, a proposed biosimilar to Eylea. MYL-1701P-3001 study was designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of MYL-1701P in the treatment of subjects with Diabetic Macular Edema (DME). Eligible subjects from MYL-1701P-3001 study will be enrolled in the AFIL-IJZ-3002 study. All enrolled subjects will receive three doses of MYL-1701P every eight weeks. Subjects will attend the clinic visits for safety and efficacy assessments including BCVA, SD-OCT, complete ophthalmological examinations during the study.
Tracking Information
- NCT #
- NCT04674800
- Collaborators
- Momenta Pharmaceuticals, Inc.
- Investigators
- Study Director: Prasanna Ganapathi, MD Mylan Inc.
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