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COMPLETEDPHASE1

First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD)

A Phase 1, Multicenter, Prospective, Open-Label, Dose Escalation Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), in Subjects With Wet AMD

NCT04747197•EyePoint Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD)

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects diagnosed with wet Age-Related Macular Degeneration (wAMD), in the study eye.
•Subject must have received ≥3 prior injections with the same anti-VEGF product: bevacizumab, ranibizumab, or aflibercept) in the 6 months prior to the Screening Visit, in the study eye.
•Demonstrated response to the intravitreal anti-vascular endothelial growth factor (VEGF) treatment in the study eye.
•Best-corrected visual acuity (BCVA) using ETDRS charts of 25 letters (20/320 Snellen equivalent) to 85 letters (20/20 Snellen equivalent).

Exclusion Criteria

•History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
•Subfoveal fibrosis or scarring \>50% of the total lesion, or atrophy in the study eye, confirmed by central reading center.
•Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia that would compromise vision in the study eye, confirmed by central reading center.
•Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of the study results.
•Active intraocular inflammation (grade trace or above) in the study eye.
•History of rhegmatogenous retinal detachment or treatment for retinal detachment or macular hole (stage 3 or 4) in the study eye.
•History of idiopathic or autoimmune-associated uveitis in either eye.
•Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
•History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye.

Locations (11)

EyePoint Investigational Site

Phoenix, Arizona, United States

EyePoint Investigational Site

Beverly Hills, California, United States

EyePoint Investigative Site

Mountain View, California, United States

EyePoint Investigational Site

Oxnard, California, United States

EyePoint Investigational Site

Melbourne, Florida, United States

EyePoint Investigational Site

St. Petersburg, Florida, United States

EyePoint Investigational Site

Springfield, Massachusetts, United States

EyePoint Investigative Site

Asheville, North Carolina, United States

EyePoint Investigational Site

Philadelphia, Pennsylvania, United States

EyePoint Investigational Site

Abilene, Texas, United States

Key Dates

Start Date

January 20, 2021

Primary Completion Date

May 11, 2022

Completion Date

May 11, 2022

Last Updated

July 19, 2023

Enrollment

ACTUAL participants

Conditions

Wet Age-related Macular Degeneration

Interventions

EYP-1901

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: July 19, 2023Data 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

First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients 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)

Study of EYP-1901 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