COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

Other

• Participants who meet any of the following exclusion criteria will be excluded from the study. 1. Ocular Exclusion Criteria for the Study Eye Only 2. Ocular Exclusion Criteria for Either Eye 3. General Exclusion Criteria For the full list of the exclusion criteria please refer to Protocol section 4.2.

• Participants will be considered eligible for participation in the study if all of the following inclusion criteria are satisfied. 1. Male or female participants, ≥18 years of age
• Participants with a diagnosis of diabetes mellitus (DM; Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association. Must have stable DM for a minimum of 3 months prior to the Screening Visit currently managed with use of oral antihyperglycemic agents, insulin, or other injectable drugs.
• Hemoglobin A1c (HbA1c) <10% at the Screening Visit.
• Able to understand, and willingness to sign, the informed consent. For US participants only: must be willing to provide access to personal health information via Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Willingness and ability to comply with all scheduled visits, restrictions, and assessments.
• For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screening Visit and for the duration of the study.
  • Ocular Inclusion Criteria for Study Eye: 7. Previously diagnosed with macular edema associated with diabetic retinopathy (DR) at any time For the full list of the inclusion criteria please refer to Protocol section 4.1