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Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD

NCT05381948•EyePoint Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at 2 dose levels: 2060 microgram (mcg) and 3090 mcg against aflibercept.

Detailed Description

This study is evaluating the 2 doses of EYP-1901 against aflibercept in a randomized study.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit.
•Documented anatomical response (that is, reduction in fluid on \[spectral-domain - optical coherence tomography (SD-OCT)\] to previous intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections in the study eye prior to the Screening Visit.
•Previously treated with at least 2 anti-VEGF intravitreal injections (that is, bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
•Received previous anti-VEGF therapy 2 to 5 weeks (14 to 35 days) in the study eye prior to Screening Visit, but no more than 42 days prior to randomization to study treatment on Day 1.
•Best corrected visual acuity (BCVA) early Treatment Diabetic Retinopathy Study (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.
•Able to understand, and willingness to sign, the informed consent and to provide access to personal health information via Health Insurance Portability and Accountability Act (HIPAA) authorization.
•Willingness and ability to comply with all scheduled visits, restrictions, and assessments.
•For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screening Visit and for the duration of the study.

Exclusion Criteria

•History of pars plana vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
•Prior treatment with Visudyne® (verteporfin), external beam radiation therapy, or transpupillary thermotherapy in the study eye.
•Previous treatment with intravitreal corticosteroid injection or device implantation in the study eye.
•Previous focal laser photocoagulation used for AMD treatment in the study eye.
•Total choroidal neovascularization (CNV) lesion size \>12 disc areas \[30.5 millimeter square (mm\^2)\] as assessed by fluorescein angiography (FA) in the study eye at the Screening Visit.
•Central subfield thickness (CST) \>350 micrometer (mcm) in the study eye at the Screening Visit or Day 1.
•Intraretinal cystic fluid \>25 mcm in diameter involving the central subfield and/or disruption of normal morphology (loss of foveal depression, disruption of external limiting membrane) secondary to cystic intraretinal fluid within the central subfield, in the study eye at the Screening Visit. Diffuse (non-cystic) intraretinal fluid would not be excluded.
•Subretinal hemorrhage in the subfoveal/juxtafoveal location and hemorrhage greater than 1 disc are (1.8 mm\^2) if located less than 200 mcm from the foveal center in the study eye at either the Screening Visit or Day 1.
•Subfoveal fibrosis, atrophy, or scarring in the center subfield in the study eye at the Screening Visit.
•Fibrosis \>50% of the total lesion, in the study eye at the Screening Visit.
+40 more criteria

Locations (67)

EyePoint Investigative Site

Phoenix, Arizona, United States

EyePoint Investigative Site

Springdale, Arkansas, United States

EyePoint Investigative Site

Beverly Hills, California, United States

EyePoint Investigative Site

Campbell, California, United States

EyePoint Investigative Site

Encino, California, United States

EyePoint Investigative Site

Fullerton, California, United States

EyePoint Investigative Site

Glendale, California, United States

EyePoint Investigative Site

Huntington Beach, California, United States

EyePoint Investigative Site

Irvine, California, United States

EyePoint Investigative Site

Pasadena, California, United States

Key Dates

Start Date

June 30, 2022

Primary Completion Date

November 29, 2023

Completion Date

April 24, 2024

Last Updated

October 15, 2025

Enrollment

161

ACTUAL participants

Conditions

Wet Age-related Macular Degeneration

Interventions

EYP-1901

DRUG

Aflibercept 2mg/0.05mL Inj,Oph

DRUG

Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD

NCT06718816

View study

ACTIVE_NOT_RECRUITINGNA

Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

NCT04932980

Wet Age-related Macular Degeneration

View study

COMPLETEDPHASE3

A Study to Compare JL14002 to Lucentis® in Subjects With Wet Age-related Macular Degeneration (wAMD)

NCT07389577

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD

Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

A Study to Compare JL14002 to Lucentis® in Subjects With Wet Age-related Macular Degeneration (wAMD)

AAVCAGsCD59 for the Treatment of Wet AMD

An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting

ADVM-022 Intravitreal Gene Therapy for Wet AMD