CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEyePoint Pharmaceuticals, Inc.
About this trial
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
Trial design
Design model
Parallel
Treatments tested in this trial
EYP-1901
DrugIntravitreal Injection
Aflibercept (2.0 mg)
DrugIntravitreal Injection
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: EYP-1901 2686 µgExperimental treatment 1 intervention
Group B: AfliberceptActive comparator 1 intervention
Trial outcomes
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
Time frame
Weeks 52 and 56Secondary outcomes
1
Rate of injection burden
Time frame
Week 56Sponsors and contacts
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Source ClinicalTrials.gov