Recruiting NCT07449923
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EYP-1901, Aflibercept (2.0 mg).
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema, DME, Diabetic Macular Edema (DME). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Brazil, Czechia, Germany, Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Interventions
- Drug EYP-1901
Intravitreal Injection - Drug Aflibercept (2.0 mg)
Intravitreal Injection
Primary outcome measures
- Average change in best corrected visual acuity (BCVA) [Time frame: Weeks 52 and 56]
Secondary outcome measures (1)
- Rate of injection burden [Time frame: Week 56]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 51 centers
- Associated Retina Consultans — Gilbert
- Associated Retina Consultants - Phoenix — Phoenix
- Phoenix Retina Clinical Trials, LLC - North Phoenix — Phoenix
- Retina Macula Institute of Arizona — Scottsdale
- Retina Vitreous Associates Medical Group — Beverly Hills
- Retina Consultants of Orange County — Fullerton
- South Coast Retina Center — Long Beach
- Retinal Consultants Medical Group - Modesto — Modesto
- … and 43 more centers
Hungary · 8 centers
- 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
Brazil · 5 centers
- 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
Czechia · 5 centers
- 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
Germany · 1 center
- St Elisabeth Krankenhaus — Cologne
Identifiers
NCT: NCT07449923 · EYP-1901-304