240 Participants NeededMy employer runs this trial

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

(DME Trial)

Recruiting at 47 trial locations
RR
Overseen ByRamiro Ribeiro, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: EyePoint Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

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.

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: EYP-1901 2686 µgExperimental Treatment1 Intervention
Group II: AfliberceptActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

EyePoint Pharmaceuticals, Inc.

Lead Sponsor

Trials
19
Recruited
2,700+