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Diabetic Macular EdemaPhase 3DMENCT07449923

CAPRI: 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 70 sites in 5 countries.

Active, not recruiting

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

Official record
Search all trials

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
70 sitesin 5 countries
Study dates
9 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

70 sites in 5 countries.

70 sites in 5 countries

United States51 sites

  • Vision Research Center at Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Retina Specialists of Colorado - Arvada

    Arvada, Colorado, 80002

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • Retina and Vitreous of Texas

    Bellaire, Texas, 77401

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Retina Center of New Jersey

    Bloomfield, New Jersey, 07003

  • Associated Vitreoretinal & Uveitis Consultants - Carmel

    Carmel, Indiana, 46032

  • Connecticut Eye Consultants, P.C.

    Danbury, Connecticut, 06810

  • Retina Vitreous Center, PLLC

    Edmond, Oklahoma, 73013

  • Retina Associates

    Elmhurst, Illinois, 60126

  • Verum Research, LLC

    Eugene, Oregon, 97401

  • The Retina Group of Washington

    Fairfax, Virginia, 22031

  • Carolinas Centers for Sight, P.C. - Florence Campus

    Florence, South Carolina, 29501

  • Retina Group of Florida - Fort Lauderdale

    Fort Lauderdale, Florida, 33308

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Associated Retina Consultans

    Gilbert, Arizona, 85297

  • Coastal Eye Surgeons, LLC

    Greenwich, Connecticut, 06830

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Mid Atlantic Retina Specialists - Hagerstown

    Hagerstown, Maryland, 21740

  • Graystone Eye - Hickory Office

    Hickory, North Carolina, 28602

  • University Retina and Macula Associates

    Lemont, Illinois, 60439

  • Retina Vitreous Surgeons of CNY, PC

    Liverpool, New York, 13088

  • South Coast Retina Center

    Long Beach, California, 90807

  • The Eye Care Institute

    Louisville, Kentucky, 40206

  • Retina Associates New Orleans

    Metairie, Louisiana, 70006

  • Retinal Consultants Medical Group - Modesto

    Modesto, California, 95356

  • Illinois Retina Associates, S.C.

    Oak Park, Illinois, 60304

  • Kaiser Permanente

    Oakland, California, 94611

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Associated Retina Consultants - Phoenix

    Phoenix, Arizona, 85020

  • Phoenix Retina Clinical Trials, LLC - North Phoenix

    Phoenix, Arizona, 85050

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • San Antonio Eye Center

    San Antonio, Texas, 78215

  • Retina Associates of South Texas

    San Antonio, Texas, 78240

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona, 85255

  • MedEye Associates

    South Miami, Florida, 33143

  • The Retina Institute

    St Louis, Missouri, 63128

  • Retina Vitreous Associates of Florida - Saint Petersburg

    St. Petersburg, Florida, 33711

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33617

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • Tyler Retina Consultants

    Tyler, Texas, 75703

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Retina Group of New England, PC

    Waterford, Connecticut, 06385

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Vitreo Retinal Associates, PC

    Worcester, Massachusetts, 01605

Other trials in United States

Hungary8 sites

  • Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest

  • Budapest Retina Associates

    Budapest

  • EPC-Honvedkorhaz

    Budapest

  • Semmelweis Egyetem

    Budapest

  • Debreceni Egyetem KK Szemklinika

    Debrecen

  • Ganglion Medical Center

    Pécs

  • PTE KK Ophthalmology Clinic (Optimum Szemeszet)

    Pécs

  • SzTE KK Szemeszeti Klinika

    Szeged

Other trials in Hungary

Brazil5 sites

  • Retina Prime at Jardim Europa Medical Center

    Aracaju

  • Centro Brasileiro de Pesquisa Clinica - Blumenau

    Blumenau

  • IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia

    São Paulo

  • Retina Clinic-Jardim America

    São Paulo

  • UNIFESP - Hospital Sao Paulo

    São Paulo

Other trials in Brazil

Czechia5 sites

  • VISUS, spol s.r.o.

    Náchod

  • Axon Clinical, s.r.o.

    Prague

  • Fakultni nemocnice Kralovske Vinohrady

    Prague

  • Vseobecna fakultni nemocnice v Praze

    Prague

  • Medical Private Care s.r.o.

    Sokolov

Other trials in Czechia

Germany1 site

  • St Elisabeth Krankenhaus

    Cologne

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, Tyrosine Kinase Inhibitor, Diabetic Macular Edema, EYP-1901

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 NCT07449923
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 start9 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
NCT07449923
Sponsor's protocol ID
EYP-1901-304
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 70 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 70 sites in United States, Hungary, Brazil, Czechia, 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 NCT07449923.

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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