CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

EyePoint Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Macular Edema (DME); Diabetic Macular Edema; DME

Treatments: Drug: Aflibercept (2.0 mg); Drug: EYP-1901

Study type: Interventional

Funder types: Industry

Identifiers

NCT07449923

EYP-1901-304

Details and patient eligibility

About

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

EYP-1901 2686 µg

Experimental group

Description:

EYP-1901

Treatment:

Drug: EYP-1901

Aflibercept

Active Comparator group

Treatment:

Drug: Aflibercept (2.0 mg)