A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 52

Phase 3

Recruiting

• Conditions: Wet Age Related Macular Degeneration; wAMD
• Interventions: Drug: Aflibercept (2.0 mg); Drug: EYP-1901

• Registration Number: NCT06668064
• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

Brief Summary

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-22
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-11-01
• Primary Completion: 2026-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Previously treated or treatment naïve patients with a documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening Visit.
• Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellen equivalent) in the study eye at the Screening Visit and on Baseline (Day 1).
• For previously-treated subjects, must have been treated with at least 2 anti-VEGF IVT injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab, or faricimab) in the previous 6 months for wAMD per standard of care in the study eye prior to the Screening Visit.

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Exclusion Criteria

• Subfoveal fibrosis, atrophy, or scarring in the center subfield.
• BCVA using ETDRS charts <20 letters (20/400 Snellen equivalent) in the fellow eye.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept	Aflibercept (2.0 mg)	-
EYP-1901 2686 µg	EYP-1901	EYP-1901

Primary Outcome Measures

Name	Time	Method
Average change in best corrected visual acuity (BCVA)	Weeks 52 and 56

Secondary Outcome Measures

Name	Time	Method
Rate of injection burden	Week 56
Average change in best corrected visual acuity (BCVA)	Week 96

Trial Locations

Locations (1)

LUGANO Study Site; 🇺🇸 Dallas, Texas, United States