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Monoclonal Antibodies

EYP-1901 for Diabetic Macular Edema (VERONA Trial)

Phase 2
Recruiting
Research Sponsored by EyePoint Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).
Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
No Placebo-Only Group

Summary

This trial compares the effectiveness and safety of two different doses of the EYP-1901 eye implant to aflibercept in treating eye conditions.

Who is the study for?
This trial is for people with diabetic macular edema (DME), a type of eye swelling. Participants must have a certain level of vision in the affected eye and have been treated with an anti-VEGF injection within the last 6 months but not less than 8 weeks before screening.
What is being tested?
The study compares two doses of EYP-1901, which is administered as an intravitreal insert, against aflibercept injections. It's designed to assess how well these treatments work and their safety for patients with DME.
What are the potential side effects?
Potential side effects may include discomfort at the injection site, increased intraocular pressure, visual disturbances, or other ocular-related issues due to the nature of intravitreal treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My vision in the study eye is between 20/200 and 20/32.
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I have been diagnosed with diabetes affecting my eye before the screening visit.
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I've had an eye injection treatment in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
Secondary study objectives
Change in best corrected visual acuity (BCVA)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: EYP-1901 2686 µgExperimental Treatment1 Intervention
EYP-1901 2686 µg, single dose
Group II: EYP-1901 1343 µgExperimental Treatment1 Intervention
EYP-1901 1343 µg, single dose
Group III: AfliberceptActive Control1 Intervention
Aflibercept 2 mg/0.05mL solution, single dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EYP-1901
2022
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

EyePoint Pharmaceuticals, Inc.Lead Sponsor
18 Previous Clinical Trials
2,678 Total Patients Enrolled
Ramiro Ribeiro, MDStudy DirectorEyePoint Pharmaceuticals
1 Previous Clinical Trials
77 Total Patients Enrolled
~0 spots leftby Jan 2025
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