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

Diabetic Macular Edema Clinical Trial

— VERONA  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06099184
• Other study ID #: EYP-1901-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 15, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: October 2023
• Source: EyePoint Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• EYP-1901
Intravitreal Injection
• Aflibercept 2Mg/0.05Ml Inj,Oph
Intravitreal Injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EyePoint Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept		Week 24
Secondary	Change in best corrected visual acuity (BCVA)		Week 24