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Diabetic Macular EdemaPhase 3DMENCT07449936

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

A Phase 3 study testing EYP-1901 and Aflibercept (2.0 mg) in people with Diabetic Macular Edema and DME, run by EyePoint Pharmaceuticals, Inc. at 73 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
EYP-1901 and Aflibercept (2.0 mg)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
73 sitesin 5 countries
Study dates
16 Feb 2026to Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

73 sites in 5 countries.

73 sites in 5 countries

United States53 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas Integrated Clinical Research

    Abilene, Texas, 79606

  • Northeast Wisconsin Retina Associates

    Appleton, Wisconsin, 54914

  • Asheville Eye Associates - Regional Medical Park

    Asheville, North Carolina, 28803

  • California Retina Consultants

    Bakersfield, California, 93309

  • Johns Hopkins Medicine - The Johns Hopkins Hospital Campus - Wilmer Eye Institute

    Baltimore, Maryland, 21287

  • Charleston Neuroscience Institute - Beaufort

    Beaufort, South Carolina, 29902

  • Advanced Research LLC Sibia Eye Institute

    Boynton Beach, Florida, 33437

  • Midwest Eye Institute - Carmel

    Carmel, Indiana, 11220

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Advance Medical Research Group, Inc

    Deerfield Beach, Florida, 33064

  • The Retina Partners

    Encino, California, 91436

  • Erie Retina Research

    Erie, Pennsylvania, 16507

  • Global Research Management, Inc.

    Glendale, California, 91204

  • Retina Associates of Michigan

    Grand Blanc, Michigan, 48439

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546

  • Retina Consultants of Carolina P.A

    Greenville, South Carolina, 29605

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Mt. Olympus Medical Research

    Houston, Texas, 77479

  • Retina Consultants of Texas

    Katy, Texas, 77494

  • Colorado Retina Associates

    Lakewood, Colorado, 80228

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Georgia Retina

    Marietta, Georgia, 30060

  • Northern California Retina Vitreous Associates Medical Group INC.

    Mountain View, California, 94040

  • Tennessee Retina

    Nashville, Tennessee, 37203

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782

  • Red River Research Partners

    Plainfield, Illinois, 60586

  • Texas Retina Associates

    Plano, Texas, 75075

  • Retina Consultants of San Diego

    Poway, California, 92064

  • California Eye Specialists Medical Group, Inc.

    Redlands, California, 92373

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • Retinal Consultants Medical Group - Parkcenter Drive

    Sacramento, California, 95825

  • Retinal Consultants Medical Group

    Sacramento, California, 95841

  • Retina Associates of Utah

    Salt Lake City, Utah, 84107

  • Retina Consultants of Texas

    Schertz, Texas, 78154

  • New England Retina Consultants

    Springfield, Massachusetts, 01107

  • Retina Vitreous Associates of Florida - Saint Petersburg

    St. Petersburg, Florida, 33711

  • Southern Vitreoretinal Associates

    Tallahassee, Florida, 32308

  • NJRetina Care Center - Teaneck

    Teaneck, New Jersey, 07666

  • NJ Retina - Toms River

    Toms River, New Jersey, 08755

  • Retina Specialists - Towson

    Towson, Maryland, 21204

  • Tulsa Retina Consultant

    Tulsa, Oklahoma, 74114

  • Tyler Retina Consultants

    Tyler, Texas, 75703

  • Virginia Retina Center

    Warrenton, Virginia, 20186

  • Retina Specialists of Tampa

    Wesley Chapel, Florida, 33544

  • Salt Lake Retina

    West Jordan, Utah, 84088

  • Haik Humble Eye Center

    West Monroe, Louisiana, 71291

  • VRCNY/Long Island Vitreoretinal Consultants

    Westbury, New York, 11590

  • Cape Fear Retinal Associates, PC

    Wilmington, North Carolina, 28401

  • Piedmont Retina Specialists, P.A. - Winston-Salem Office

    Winston-Salem, North Carolina, 27103

Other trials in United States

Israel8 sites

  • 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

Other trials in Israel

Poland6 sites

  • 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

Other trials in Poland

Slovakia4 sites

  • Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

    Banská Bystrica

  • Oftalmocentrum Betliarska

    Bratislava

  • Nemocnica Poprad

    Poprad

  • Nemocnica s poliklinikou Trebisov a.s.

    Trebišov

Other trials in Slovakia

Germany2 sites

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden

  • Augenklinik Universitaetsmedizin der Johannes Gutenberg-Univ.

    Mainz

Other trials in Germany

About this study

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)

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

Being tested
EYP-1901, Aflibercept (2.0 mg)
Keywords
EyePoint, EYP-1901, Tyrosine Kinase Inhibitor, Diabetic Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EYP-1901Drug

    Intravitreal Injection

  • Aflibercept (2.0 mg)Drug

    Intravitreal Injection

Study groups in NCT07449936
Study groupRoleWhat they receive
EYP-1901 2686 µgExperimentalEYP-1901
Receives: Drug: EYP-1901
AfliberceptActive comparatorNot described
Receives: Drug: Aflibercept (2.0 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Weeks 52 and 56

Secondary outcomes (1)

  1. Rate of injection burden

    Measured: Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2026
  2. Study start16 Feb 2026
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07449936
Sponsor's protocol ID
EYP-1901-303
Acronym
DME
Status last verified
Oct 2026
First submitted
27 Feb 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EYP-1901 and Aflibercept (2.0 mg) in people with Diabetic Macular Edema and DME, run by EyePoint Pharmaceuticals, Inc. at 73 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Israel, Poland, Slovakia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average change in best corrected visual acuity (BCVA) (time frame: Weeks 52 and 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07449936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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