Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)

Phase 2

Completed

• Conditions: Wet Age-related Macular Degeneration
• Interventions: Drug: Aflibercept 2Mg/0.05Ml Inj,Oph; Drug: Eyp-1901

• Registration Number: NCT05381948
• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

Brief Summary

This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at two dose levels: 2060 ug and 3090 ug against Aflibercept.

Detailed Description

This study is evaluating the two doses of 1901 against Aflibercept in a randomized study.

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-19
• Study Start: 2022-07-28
• Status Verified: 2023-05
• Primary Completion: 2023-11-07
• Study Completion: 2024-04-24
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit.
• Previously treated with at least two anti VEGF intravitreal injections (i.e., bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
• BCVA ETDRS letter score of 35 letters (20/200 Snellen equivalent) to 85 letters (20/20 Snellen equivalent) in the study eye at the Screening Visit and on Day 1.

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Exclusion Criteria

• Central subfield thickness (CST) > 350 µm in the study eye at the Screening Visit or Day 1.
• Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma).
• Historical or active intraocular inflammation (grade trace or above) in the study eye, other than expected findings from routine cataract surgery.

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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 \[0.05mL\] every 8 weeks
EYP-1901 2060 ug	Eyp-1901	EYP-1901 2060 ug, single dose
EYP-1901 3090 ug	Eyp-1901	EYP-1901 3090 ug, single dose

Primary Outcome Measures

Name	Time	Method
Average change in best corrected visual acuity (BCVA)	Week 28 and Week 32

Secondary Outcome Measures

Name	Time	Method
Number of rescue injections	Week 56
Mean change in central retinal thickness on optical coherence tomography (OCT)	Baseline, Week 56
Change in best corrected visual acuity (BCVA)	Baseline, Week 56

Trial Locations

Locations (2)

EyePoint Investigative Site; 🇺🇸 Silverdale, Washington, United States

EyePoint Investigative Sites; 🇺🇸 Houston, Texas, United States