Clinical Trials in the USA / NCT07449923
Active, not recruiting
Phase 3
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
NCT07449923 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Diabetic Macular EdemaDMEDiabetic Macular Edema (DME)
Investigational drug(s) / intervention(s)
EYP-1901: Intravitreal Injection
Aflibercept (2.0 mg): Intravitreal Injection
Study summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Eligibility
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:
* BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.
Primary outcome measure(s)
- Average change in best corrected visual acuity (BCVA) — Weeks 52 and 56
BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score change from Baseline to the average of Weeks 52 and 56
Trial sites (70)
| Facility | City | Region | Status |
|---|---|---|---|
| Associated Retina Consultans | Gilbert | Arizona | |
| Associated Retina Consultants - Phoenix | Phoenix | Arizona | |
| Phoenix Retina Clinical Trials, LLC - North Phoenix | Phoenix | Arizona | |
| Retina Macula Institute of Arizona | Scottsdale | Arizona | |
| Retina Vitreous Associates Medical Group | Beverly Hills | California | |
| Retina Consultants of Orange County | Fullerton | California | |
| South Coast Retina Center | Long Beach | California | |
| Retinal Consultants Medical Group - Modesto | Modesto | California | |
| Kaiser Permanente | Oakland | California | |
| Retina Consultants of Southern California | Redlands | California | |
| Bay Area Retina Associates | Walnut Creek | California | |
| Retina Specialists of Colorado - Arvada | Arvada | Colorado | |
| Connecticut Eye Consultants, P.C. | Danbury | Connecticut | |
| Coastal Eye Surgeons, LLC | Greenwich | Connecticut | |
| Retina Group of New England, PC | Waterford | Connecticut | |
| Retina Group of Florida - Fort Lauderdale | Fort Lauderdale | Florida | |
| Retina Specialty Institute | Pensacola | Florida | |
| Fort Lauderdale Eye Institute | Plantation | Florida | |
| MedEye Associates | South Miami | Florida | |
| Retina Vitreous Associates of Florida - Saint Petersburg | St. Petersburg | Florida | |
| Retina Vitreous Associates of Florida | Tampa | Florida | |
| Retina Associates | Elmhurst | Illinois | |
| University Retina and Macula Associates | Lemont | Illinois | |
| Illinois Retina Associates, S.C. | Oak Park | Illinois | |
| Associated Vitreoretinal & Uveitis Consultants - Carmel | Carmel | Indiana | |
| The Eye Care Institute | Louisville | Kentucky | |
| Retina Associates New Orleans | Metairie | Louisiana | |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | |
| Mid Atlantic Retina Specialists - Hagerstown | Hagerstown | Maryland | |
| Vitreo Retinal Associates, PC | Worcester | Massachusetts | |
| The Retina Institute | St Louis | Missouri | |
| Retina Center of New Jersey | Bloomfield | New Jersey | |
| Vision Research Center at Eye Associates of New Mexico | Albuquerque | New Mexico | |
| Retina Vitreous Surgeons of CNY, PC | Liverpool | New York | |
| Graystone Eye - Hickory Office | Hickory | North Carolina | |
| North Carolina Retina Associates | Wake Forest | North Carolina | |
| Retina Vitreous Center, PLLC | Edmond | Oklahoma | |
| Verum Research, LLC | Eugene | Oregon | |
| Wills Eye Hospital | Philadelphia | Pennsylvania | |
| Carolinas Centers for Sight, P.C. - Florence Campus | Florence | South Carolina |
+ 30 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07449923 on ClinicalTrials.gov ↗ ← All trials in the USA