INSIGHT Trial: Aflibercept Biosimilar vs. Reference Drug in Diabetic Macular Edema

A Phase-III randomized clinical trial (NCT03610646) comparing the biosimilar MYL-1701P/Yesafili™ with reference aflibercept (Eylea®) for treating diabetic macular edema. The dataset includes subgroup analyses for 355 participants, tracking best corrected visual acuity and central subfield thickness outcomes at 8 and 52 weeks. The data was published by Susan B. Bressler on figshare under a CC-BY-4.0 license.

Use Cases

• Compare visual acuity outcomes between biosimilar and reference drugs based on BCVA change from baseline.
• Analyze treatment response across patient subgroups based on stratification by baseline CST, HbA1c, age, and gender.
• Assess central subfield thickness changes over time based on CST measurements at Weeks 8 and 52.
• Evaluate clinical equivalence in specific demographic cohorts based on race, ethnicity, and region subgroups.

Strengths

• Data originates from a pivotal Phase-III randomized clinical trial (INSIGHT) with a ClinicalTrials.gov identifier (NCT03610646).
• Includes results for 355 participants (179 receiving biosimilar, 176 receiving reference drug) with specific outcome measures like mean BCVA change and 90% confidence intervals.
• Provides detailed subgroup analyses stratified by 9 baseline characteristics including BCVA, CST, HbA1c, and anti-drug antibody status.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment.
• The primary data files are in PDF and DOCX formats (1.4 MB total), which may require extraction for quantitative analysis.

Provenance

Source

figshare, authored by Susan B. Bressler.

Collection Method

Subgroup analysis from the INSIGHT randomized clinical trial.

Time Range

Clinical trial period, with measurements at baseline, Week 8, and Week 52.

Freshness

Last updated 2026-05-18 11:20:52; freshness should be verified.