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

EyePoint Pharmaceuticals, Inc.2 sites in 1 country17 target enrollmentJanuary 20, 2021

ConditionsWet Age-related Macular Degeneration

InterventionsEYP-1901

DrugsEYP-1901

Overview

Phase: Phase 1
Intervention: EYP-1901
Conditions: Wet Age-related Macular Degeneration
Sponsor: EyePoint Pharmaceuticals, Inc.
Enrollment: 17
Locations: 2
Primary Endpoint: Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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)

Registry

clinicaltrials.gov

Start Date

January 20, 2021

End Date

May 11, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

EyePoint Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.