Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)

Phase 2

Not yet recruiting

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Aflibercept 2Mg/0.05Ml Inj,Oph; Drug: EYP-1901

• Registration Number: NCT06099184
• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

Brief Summary

A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept

Detailed Description

A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-05
• Study Start: 2024-01-15
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
• Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.
• 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).

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Exclusion Criteria

• Any current or history of ocular disease other than DME
• BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
• Active ocular inflammation or active infection in either eye at Baseline (Day 1).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept	Aflibercept 2Mg/0.05Ml Inj,Oph	Aflibercept 2 mg/0.05mL solution, single dose
EYP-1901 1343 µg	EYP-1901	EYP-1901 1343 µg, single dose
EYP-1901 2686 µg	EYP-1901	EYP-1901 2686 µg, single dose

Primary Outcome Measures

Name	Time	Method
Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept	Week 24	Timing of supplemental injection

Secondary Outcome Measures

Name	Time	Method
Change in best corrected visual acuity (BCVA)	Week 24	Changes in BCVA

Trial Locations

Locations (1)

EyePoint Investigative Site; 🇺🇸 Lynchburg, Virginia, United States