Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. Subjects to receive the assigned treatment until Week 48. All subjects to return to clinic every 4 weeks to assess safety, efficacy and to guide treatment. Additional visits allowed during the study as specified in the study schedule for safety and pharmacokinetic evaluation. Pharmacokinetics (PK) and Immunogenicity to be assessed in the subjects participating in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
355
Subjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8
Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Time frame: Baseline and 8 weeks
The Mean Change From Baseline in Central Retinal Thickness (CRT)
The mean change from baseline in Central Retinal Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT) over time
Time frame: From baseline to week 52
The Mean Change in BCVA
Mean change from baseline in BCVA as assessed by ETDRS letters over time. Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening
Time frame: From baseline to week 52
Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA
Number of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time
Time frame: From baseline to week 52
Number of Administrations of Study Drug Required
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Mylan Investigator Site
Phoenix, Arizona, United States
Mylan Investigator Site
Phoenix, Arizona, United States
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Sacramento, California, United States
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St. Petersburg, Florida, United States
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Winter Haven, Florida, United States
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Augusta, Georgia, United States
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Shawnee Mission, Kansas, United States
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Paducah, Kentucky, United States
Mylan Investigator Site
Chevy Chase, Maryland, United States
Mylan Investigator Site
Ladson, South Carolina, United States
...and 63 more locations
The mean number of doses administered during the 52 weeks of study
Time frame: From baseline to week 52
Number of Participants With Treatment Emergent Adverse Events
Number of Participants with Treatment Emergent Adverse Events (Safety and tolerability)
Time frame: From baseline to week 52
Number of Subjects With Induced and Boosted Anti-Drug Antibodies
Number of subjects with induced and boosted Anti-Drug Antibodies (ADA) (Immunogenicity)
Time frame: From baseline to week 52
Concentration of Aflibercept in Blood (Pharmacokinetics)
Free Drug Concentration of aflibercept in blood (Pharmacokinetics)
Time frame: 2 Days after Week 16 Injection