Trials / Completed
CompletedNCT04674800
Extension Study of MYL-1701P-3001 for Safety and Efficacy
A Multi Center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects With Diabetic Macular Edema Completed MYL-1701P-3001 Study.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Mylan Pharmaceuticals Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 study.
Detailed 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-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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MYL-1701P, a proposed biosimilar to Eylea | Open label and single arm |
Timeline
- Start date
- 2020-11-23
- Primary completion
- 2022-04-20
- Completion
- 2022-04-20
- First posted
- 2020-12-19
- Last updated
- 2022-08-26
Locations
15 sites across 1 country: India
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04674800. Inclusion in this directory is not an endorsement.