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 (NCT03610646) study.
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 (NCT03610646) 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 (NCT03610646) 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 Best Corrected Visual Acuity (BCVA), Spectral domain- Optical Coherence Tomography (SD-OCT), complete ophthalmological examinations during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
MYL-1701P- 3 doses each of 2 mg at 8 weeks interval
Mylan Investigative site
Hyderabad, Andhra Pradesh, India
Mylan Investigative Site
Visakhapatnam, Andhra Pradesh, India
Mylan Investigative Site
Ahmedabad, Gujarat, India
Incidence of Treatment Emergent Adverse Events (TEAEs).
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
Time frame: Week 20
Change From Baseline in BCVA at Week 8
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Time frame: Week 8
Change From Baseline in CRT at Week 8
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Time frame: Weeks 8
Change From Baseline in BCVA at Week 16
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Time frame: Week 16
Change From Baseline in BCVA at Week 20
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Time frame: Week 20
Change From Baseline in CRT at Week 16
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Time frame: Week 16
Change From Baseline in CRT at Week 20
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
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Mylan Investigative site
Ahmedabad, Gujarat, India
Mylan Investigative site
Bangalore, Karnataka, India
Mylan Investigative Site
Bangalore, Karnataka, India
Mylan Investigative Site
Bengaluru, Karnataka, India
Mylan Investigative Site
Mumbai, Maharashtra, India
Mylan Investigative site
New Delhi, New Delhi, India
Mylan Investigative site
Bhubaneswar, Odisha, India
...and 5 more locations
Time frame: Week 20