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

• Sponsor: EyePoint Pharmaceuticals, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06099184
• Collaborator: (none)
• Enrollment: 25
• Arms: 3
• Anticipated Duration (Months): 12

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: EYP-1901; Drug: Aflibercept 2Mg/0.05Ml Inj,Oph	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME)
• Anticipated Study Start Date: Jan 15, 2024
• Anticipated Primary Completion Date: Jan 15, 2025
• Anticipated Study Completion Date: Jan 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EYP-1901 1340 µg EYP-1901 1340 µg, single dose	Drug: EYP-1901; Intravitreal Injection
Experimental: EYP-1901 2680 µg EYP-1901 2680 µg, single dose	Drug: EYP-1901; Intravitreal Injection
Active Comparator: Aflibercept Aflibercept 2 mg/0.05mL solution, single dose	Drug: Aflibercept 2Mg/0.05Ml Inj,Oph; Intravitreal Injection

Outcome Measures

Primary Outcome Measures

1. Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept [Week 24]

Secondary Outcome Measures

1. Change in best corrected visual acuity (BCVA) [Week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• EyePoint Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EyePoint Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT06099184
• Other Study ID Numbers: EYP-1901-202
• First Posted: Oct 25, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by EyePoint Pharmaceuticals, Inc.: DME; EYP-1901; EyePoint
• Additional relevant MeSH terms: Macular Edema; Edema; Aflibercept

Study Results

No Results Posted as of Oct 25, 2023