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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEyePoint Pharmaceuticals, Inc.

About this trial

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Eligibility criteria

Qualifiers

Previously treated or treatment naïve patients with a documented diagnosis of macular edema associated with diabetic retinopathy (DR) in the study eye, with onset of disease that began at any time prior to the Screening Visit.

Best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 78 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).

For previously treated participants: at least 1 injection of anti-VEGF in the past 12 months, the most recent anti-VEGF treatment for DME must not have been administered less than 12 weeks prior to the Screening Visit.

Disqualifiers

BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.

Trial design

Treatments tested in this trial

  • EYP-1901
  • Aflibercept (2.0 mg)

Treatment groups

240 Participants
are divided into 2 treatment groups

Locations

65
Germany
Augenklinik Universitaetsmedizin der Johannes Gutenberg-Univ. Mainz Germany
Israel
Shamir Medical Center Ophthalmology Out Patient Clinic Be’er Ya‘aqov Israel
Bnai Zion Medical Center Haifa Israel
Carmel Medical Center Haifa Israel

Sponsors and collaborators

EyePoint Pharmaceuticals, Inc.

Lead sponsor