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

Conditions

• DME
• Diabetic Macular Edema
• Diabetic Macular Edema (DME)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EYP-1901 — DRUG
  Intravitreal Injection
• Aflibercept (2.0 mg) — DRUG
  Intravitreal Injection

Study Details

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

Key Dates

Start date

Feb 16, 2026

Status verified

Jun 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2028

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: EYP-1901 2686 µg
  EYP-1901
• Active Comparator: Aflibercept

Primary Outcome Measure

Average change in best corrected visual acuity (BCVA) [ Time Frame: Weeks 52 and 56 ]

Central Contacts

• Ramiro Ribeiro, MD, PhD
  833-393-7646
  [email protected]

Locations (50)

Find similar trials in Bakersfield, CA

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