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Active, not recruitingNCT07449936DMEUpdated Oct 2, 2026

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

A Phase 3 interventional study of EYP-1901 and Aflibercept (2.0 mg) in Diabetic Macular Edema, DME and Diabetic Macular Edema (DME), sponsored by EyePoint Pharmaceuticals, Inc.. Active, not recruiting at 73 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by EyePoint Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

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

Keywords

  • EyePoint
  • EYP-1901
  • Tyrosine Kinase Inhibitor
  • Diabetic Macular Edema
03

In context

Lead sponsor

EyePoint Pharmaceuticals, Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    EYP-1901 2686 µg

    EYP-1901

    Drug: EYP-1901

  • Active comparator
    Aflibercept

    Drug: Aflibercept (2.0 mg)

Interventions

  • DrugEYP-1901

    Intravitreal Injection

  • DrugAflibercept (2.0 mg)

    Intravitreal Injection

06

What researchers measure

Primary outcomes

  1. Average change in best corrected visual acuity (BCVA)

    BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score change from Baseline to the average of Weeks 52 and 56

    Time frame: Weeks 52 and 56

Secondary outcomes

  1. Rate of injection burden

    Time frame: Week 56

07

Study locations

73 sites
  • California Retina Consultants
    Bakersfield, California 93309, United States
  • The Retina Partners
    Encino, California 91436, United States
  • Global Research Management, Inc.
    Glendale, California 91204, United States
  • Northern California Retina Vitreous Associates Medical Group INC.
    Mountain View, California 94040, United States
  • Retina Consultants of San Diego
    Poway, California 92064, United States
  • California Eye Specialists Medical Group, Inc.
    Redlands, California 92373, United States
  • Retinal Consultants Medical Group - Parkcenter Drive
    Sacramento, California 95825, United States
  • Retinal Consultants Medical Group
    Sacramento, California 95841, United States
  • Retina Consultants of Southern Colorado
    Colorado Springs, Colorado 80909, United States
  • Colorado Retina Associates
    Lakewood, Colorado 80228, United States
  • Advanced Research LLC Sibia Eye Institute
    Boynton Beach, Florida 33437, United States
  • Advance Medical Research Group, Inc
    Deerfield Beach, Florida 33064, United States
  • Eye Associates of Pinellas
    Pinellas Park, Florida 33782, United States
  • Retina Vitreous Associates of Florida - Saint Petersburg
    St. Petersburg, Florida 33711, United States
  • Southern Vitreoretinal Associates
    Tallahassee, Florida 32308, United States
  • Retina Specialists of Tampa
    Wesley Chapel, Florida 33544, United States
  • Georgia Retina
    Marietta, Georgia 30060, United States
  • Retina Consultants of Hawaii
    ‘Aiea, Hawaii 96701, United States
  • Red River Research Partners
    Plainfield, Illinois 60586, United States
  • Midwest Eye Institute - Carmel
    Carmel, Indiana 11220, United States
  • Haik Humble Eye Center
    West Monroe, Louisiana 71291, United States
  • Johns Hopkins Medicine - The Johns Hopkins Hospital Campus - Wilmer Eye Institute
    Baltimore, Maryland 21287, United States
  • Retina Group of Washington
    Chevy Chase, Maryland 20815, United States
  • Cumberland Valley Retina Consultants
    Hagerstown, Maryland 21740, United States
  • Retina Specialists - Towson
    Towson, Maryland 21204, United States
  • New England Retina Consultants
    Springfield, Massachusetts 01107, United States
  • Retina Associates of Michigan
    Grand Blanc, Michigan 48439, United States
  • Foundation for Vision Research
    Grand Rapids, Michigan 49546, United States
  • Sierra Eye Associates
    Reno, Nevada 89502, United States
  • NJRetina Care Center - Teaneck
    Teaneck, New Jersey 07666, United States
  • NJ Retina - Toms River
    Toms River, New Jersey 08755, United States
  • Retina Associates of Western New York
    Rochester, New York 14620, United States
  • VRCNY/Long Island Vitreoretinal Consultants
    Westbury, New York 11590, United States
  • Asheville Eye Associates - Regional Medical Park
    Asheville, North Carolina 28803, United States
  • Cape Fear Retinal Associates, PC
    Wilmington, North Carolina 28401, United States
  • Piedmont Retina Specialists, P.A. - Winston-Salem Office
    Winston-Salem, North Carolina 27103, United States
  • Tulsa Retina Consultant
    Tulsa, Oklahoma 74114, United States
  • Erie Retina Research
    Erie, Pennsylvania 16507, United States
  • Charleston Neuroscience Institute - Beaufort
    Beaufort, South Carolina 29902, United States
  • Retina Consultants of Carolina P.A
    Greenville, South Carolina 29605, United States
  • Tennessee Retina
    Nashville, Tennessee 37203, United States
  • Retina Research Institute of Texas Integrated Clinical Research
    Abilene, Texas 79606, United States
  • Texas Retina Associates
    Dallas, Texas 75231, United States
  • Mt. Olympus Medical Research
    Houston, Texas 77479, United States
  • Retina Consultants of Texas
    Katy, Texas 77494, United States
  • Texas Retina Associates
    Plano, Texas 75075, United States
  • Retina Consultants of Texas
    Schertz, Texas 78154, United States
  • Tyler Retina Consultants
    Tyler, Texas 75703, United States
  • Retina Associates of Utah
    Salt Lake City, Utah 84107, United States
  • Salt Lake Retina
    West Jordan, Utah 84088, United States
  • Piedmont Eye Center
    Lynchburg, Virginia 24502, United States
  • Virginia Retina Center
    Warrenton, Virginia 20186, United States
  • Northeast Wisconsin Retina Associates
    Appleton, Wisconsin 54914, United States
  • Universitatsklinikum Carl Gustav Carus Dresden
    Dresden, Germany
  • Augenklinik Universitaetsmedizin der Johannes Gutenberg-Univ.
    Mainz, Germany
  • Shamir Medical Center Ophthalmology Out Patient Clinic
    Be’er Ya‘aqov, Israel
  • Bnai Zion Medical Center
    Haifa, Israel
  • Carmel Medical Center
    Haifa, Israel
  • Rambam Health Care Campus (RHCC)
    Haifa, Israel
  • Meir Medical Center Ophthalmology Department
    Kfar Saba, Israel
  • Rabin Medical Center
    Petah Tikva, Israel
  • Kaplan Medical Center
    Rehovot, Israel
  • The Tel-Aviv Sourasky Medical Centre
    Tel Aviv, Israel
  • Oculomedica Sp. z o.o.
    Bydgoszcz, Poland
  • OFTALMIKA Sp. z o.o
    Bydgoszcz, Poland
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
    Lublin, Poland
  • Centrum Diagnostyki i Mikrochirurgii Oka -LENS Sp. z o. o
    Olsztyn, Poland
  • Centrum Medyczne UNO-MED
    Tarnów, Poland
  • Warszawski Szpital Okulistyczny
    Warsaw, Poland
  • Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
    Banská Bystrica, Slovakia
  • Oftalmocentrum Betliarska
    Bratislava, Slovakia
  • Nemocnica Poprad
    Poprad, Slovakia
  • Nemocnica s poliklinikou Trebisov a.s.
    Trebišov, Slovakia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and site details
1 update, last Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Minor edits only
    + 2 other changes: verification date and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07449936
Lead sponsor
EyePoint Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Mar 4, 2026
Start date
Feb 16, 2026
Primary completion
Oct 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Oct 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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