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Recruiting NCT07449936

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

Phase III Interventional Diabetic Macular Edema DME Diabetic Macular Edema (DME)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EYP-1901, Aflibercept (2.0 mg).
Who it may be relevant to
Registry conditions: Diabetic Macular Edema, DME, Diabetic Macular Edema (DME). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany, Israel, Poland, Slovakia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)

Overview

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

Interventions

  • Drug EYP-1901
    Intravitreal Injection
  • Drug Aflibercept (2.0 mg)
    Intravitreal Injection

Primary outcome measures

  • Average change in best corrected visual acuity (BCVA) [Time frame: Weeks 52 and 56]
Secondary outcome measures (1)
  • Rate of injection burden [Time frame: Week 56]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 53 centers
  • California Retina Consultants — Bakersfield
  • The Retina Partners — Encino
  • Global Research Management, Inc. — Glendale
  • Northern California Retina Vitreous Associates Medical Group INC. — Mountain View
  • Retina Consultants of San Diego — Poway
  • California Eye Specialists Medical Group, Inc. — Redlands
  • Retinal Consultants Medical Group - Parkcenter Drive — Sacramento
  • Retinal Consultants Medical Group — Sacramento
  • … and 45 more centers
Israel · 8 centers
  • Shamir Medical Center Ophthalmology Out Patient Clinic — Be’er Ya‘aqov
  • Bnai Zion Medical Center — Haifa
  • Carmel Medical Center — Haifa
  • Rambam Health Care Campus (RHCC) — Haifa
  • Meir Medical Center Ophthalmology Department — Kfar Saba
  • Rabin Medical Center — Petah Tikva
  • Kaplan Medical Center — Rehovot
  • The Tel-Aviv Sourasky Medical Centre — Tel Aviv
Poland · 6 centers
  • Oculomedica Sp. z o.o. — Bydgoszcz
  • OFTALMIKA Sp. z o.o — Bydgoszcz
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie — Lublin
  • Centrum Diagnostyki i Mikrochirurgii Oka -LENS Sp. z o. o — Olsztyn
  • Centrum Medyczne UNO-MED — Tarnów
  • Warszawski Szpital Okulistyczny — Warsaw
Slovakia · 4 centers
  • Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica — Banská Bystrica
  • Oftalmocentrum Betliarska — Bratislava
  • Nemocnica Poprad — Poprad
  • Nemocnica s poliklinikou Trebisov a.s. — Trebišov
Germany · 2 centers
  • Universitatsklinikum Carl Gustav Carus Dresden — Dresden
  • Augenklinik Universitaetsmedizin der Johannes Gutenberg-Univ. — Mainz

Identifiers

NCT: NCT07449936 · EYP-1901-303

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗