CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
DME
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)
1 other identifier
interventional
240
5 countries
70
Brief Summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2026
Typical duration for phase_3
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2026
CompletedFirst Submitted
Initial submission to the registry
February 27, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
October 2, 2026
October 1, 2026
1.6 years
February 27, 2026
October 1, 2026
Conditions
Keywords
Outcome Measures
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
Weeks 52 and 56
Secondary Outcomes (1)
Rate of injection burden
Week 56
Study Arms (2)
EYP-1901 2686 µg
EXPERIMENTALEYP-1901
Aflibercept
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Associated Retina Consultans
Gilbert, Arizona, 85297, United States
Associated Retina Consultants - Phoenix
Phoenix, Arizona, 85020, United States
Phoenix Retina Clinical Trials, LLC - North Phoenix
Phoenix, Arizona, 85050, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
South Coast Retina Center
Long Beach, California, 90807, United States
Retinal Consultants Medical Group - Modesto
Modesto, California, 95356, United States
Kaiser Permanente
Oakland, California, 94611, United States
Retina Consultants of Southern California
Redlands, California, 92374, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Retina Specialists of Colorado - Arvada
Arvada, Colorado, 80002, United States
Connecticut Eye Consultants, P.C.
Danbury, Connecticut, 06810, United States
Coastal Eye Surgeons, LLC
Greenwich, Connecticut, 06830, United States
Retina Group of New England, PC
Waterford, Connecticut, 06385, United States
Retina Group of Florida - Fort Lauderdale
Fort Lauderdale, Florida, 33308, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
MedEye Associates
South Miami, Florida, 33143, United States
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, 33711, United States
Retina Vitreous Associates of Florida
Tampa, Florida, 33617, United States
Retina Associates
Elmhurst, Illinois, 60126, United States
University Retina and Macula Associates
Lemont, Illinois, 60439, United States
Illinois Retina Associates, S.C.
Oak Park, Illinois, 60304, United States
Associated Vitreoretinal & Uveitis Consultants - Carmel
Carmel, Indiana, 46032, United States
The Eye Care Institute
Louisville, Kentucky, 40206, United States
Retina Associates New Orleans
Metairie, Louisiana, 70006, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland, 21740, United States
Vitreo Retinal Associates, PC
Worcester, Massachusetts, 01605, United States
The Retina Institute
St Louis, Missouri, 63128, United States
Retina Center of New Jersey
Bloomfield, New Jersey, 07003, United States
Vision Research Center at Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York, 13088, United States
Graystone Eye - Hickory Office
Hickory, North Carolina, 28602, United States
North Carolina Retina Associates
Wake Forest, North Carolina, 27587, United States
Retina Vitreous Center, PLLC
Edmond, Oklahoma, 73013, United States
Verum Research, LLC
Eugene, Oregon, 97401, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Carolinas Centers for Sight, P.C. - Florence Campus
Florence, South Carolina, 29501, United States
Charles Retina Institute
Germantown, Tennessee, 38138, United States
Austin Clinical Research LLC
Austin, Texas, 78750, United States
Retina and Vitreous of Texas
Bellaire, Texas, 77401, United States
Retina Consultants of Texas
Bellaire, Texas, 77401, United States
San Antonio Eye Center
San Antonio, Texas, 78215, United States
Retina Associates of South Texas
San Antonio, Texas, 78240, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
Tyler Retina Consultants
Tyler, Texas, 75703, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
The Retina Group of Washington
Fairfax, Virginia, 22031, United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, 54403, United States
Retina Prime at Jardim Europa Medical Center
Aracaju, Brazil
Centro Brasileiro de Pesquisa Clinica - Blumenau
Blumenau, Brazil
IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia
São Paulo, Brazil
Retina Clinic-Jardim America
São Paulo, Brazil
UNIFESP - Hospital Sao Paulo
São Paulo, Brazil
VISUS, spol s.r.o.
Náchod, Czechia
Axon Clinical, s.r.o.
Prague, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Medical Private Care s.r.o.
Sokolov, Czechia
St Elisabeth Krankenhaus
Cologne, Germany
Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, Hungary
Budapest Retina Associates
Budapest, Hungary
EPC-Honvedkorhaz
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Debreceni Egyetem KK Szemklinika
Debrecen, Hungary
Ganglion Medical Center
Pécs, Hungary
PTE KK Ophthalmology Clinic (Optimum Szemeszet)
Pécs, Hungary
SzTE KK Szemeszeti Klinika
Szeged, Hungary
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2026
First Posted
March 4, 2026
Study Start
February 9, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2028
Last Updated
October 2, 2026
Record last verified: 2026-10