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240 Participants NeededMy employer runs this trial

EYP-1901 vs Aflibercept for Diabetic Macular Edema

(DME Trial)

Recruiting at 44 trial locations
RR
Overseen ByRamiro Ribeiro, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: EyePoint Pharmaceuticals, Inc.
Must be taking: Anti-VEGF
Disqualifiers: Low vision, others
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
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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

I have diabetic eye swelling and have been diagnosed by a doctor.
* 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).
I had at least one anti-VEGF injection in the past year, with my last one over 12 weeks ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EYP-1901 or Aflibercept in a double-masked manner

52 weeks
Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aflibercept
  • EYP-1901

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+

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