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.
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
- Conditions the study is for
- Diabetic Macular Edema, DME, Diabetic Macular Edema (DME)
- 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
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
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
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
Germany2 sites
Universitatsklinikum Carl Gustav Carus Dresden
Dresden
Augenklinik Universitaetsmedizin der Johannes Gutenberg-Univ.
Mainz
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.
- Conditions
- Diabetic Macular Edema, DME, Diabetic Macular Edema (DME)
- 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 group | Role | What they receive |
|---|---|---|
| EYP-1901 2686 µg | Experimental | EYP-1901 Receives: Drug: EYP-1901 |
| Aflibercept | Active comparator | Not described Receives: Drug: Aflibercept (2.0 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted4 Mar 2026
- Study start16 Feb 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07449936
- Acronym / sponsor ID
- DME / EYP-1901-303
- Conditions
- Diabetic Macular Edema, DME, Diabetic Macular Edema (DME)
- Keywords
- EyePoint, EYP-1901, Tyrosine Kinase Inhibitor, Diabetic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EYP-1901 2686 µg | Experimental | Drug: EYP-1901EYP-1901 |
| Aflibercept | Active comparator | Drug: Aflibercept (2.0 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EYP-1901Intravitreal Injection | Drug | EYP-1901 2686 µg |
| Aflibercept (2.0 mg)Intravitreal Injection | Drug | Aflibercept |
Primary outcome
Average change in best corrected visual acuity (BCVA)
Time frame: Weeks 52 and 56
BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score change from Baseline to the average of Weeks 52 and 56
1 secondary outcome
Rate of injection burden
Time frame: Week 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Macular Edema
RecruitingPhase 4
Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
Diabetic Retinal Disease
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A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
Diabetic Retinopathy, Macular Edema
Not yet recruitingPhase 2
Study of CU06-1004 in Patients With Daibetic Macular Edema
DME, Diabetic Macular Edema
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
Diabetic Retinopathy, Macular Edema
Active, not recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
73 sites in 5 countries: see every site and its status.
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?
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.