18 and older, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8Primary· Baseline and 8 weeks
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.
Group
Value
95% CI
MYL-1701P
6.60
± 0.548
Eylea
6.56
± 0.548
The Mean Change From Baseline in Central Retinal Thickness (CRT)Secondary· From baseline to week 52
The mean change from baseline in Central Retinal Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT) over time
Group
Value
95% CI
MYL-1701P
-170.14
± 7.198
Eylea
-167.67
± 7.260
The Mean Change in BCVASecondary· From baseline to week 52
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
Group
Value
95% CI
MYL-1701P
10.76
± 0.619
Eylea
10.52
± 0.621
Number of Subjects Who Gained ≥15 Letters From Baseline in BCVASecondary· From baseline to week 52
Number of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time
Group
Value
95% CI
MYL-1701P
57
Eylea
51
Number of Administrations of Study Drug RequiredSecondary· From baseline to week 52
The mean number of doses administered during the 52 weeks of study
Group
Value
95% CI
MYL-1701P
8.4
± 2.06
Eylea
8.7
± 1.76
Number of Participants With Treatment Emergent Adverse EventsSecondary· From baseline to week 52
Number of Participants with Treatment Emergent Adverse Events (Safety and tolerability)
Group
Value
95% CI
MYL-1701P
138
Eylea
138
Number of Subjects With Induced and Boosted Anti-Drug AntibodiesSecondary· From baseline to week 52
Number of subjects with induced and boosted Anti-Drug Antibodies (ADA) (Immunogenicity)
Group
Value
95% CI
MYL-1701P
5
Eylea
10
Concentration of Aflibercept in Blood (Pharmacokinetics)Secondary· 2 Days after Week 16 Injection
Free Drug Concentration of aflibercept in blood (Pharmacokinetics)
Group
Value
95% CI
MYL-1701P
34.355
± 30.693
Eylea
30.758
± 32.3208
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to 52 Weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mylan Pharmaceuticals Inc
Last refreshed: 7 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03610646.