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

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)

Study Overview

• Status: Completed
• Conditions: Wet Age-related Macular Degeneration
• Intervention / Treatment: Drug: EYP-1901

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • EyePoint Investigational Site
  • California
    • Beverly Hills, California, United States, 90211
      • EyePoint Investigational Site
    • Mountain View, California, United States, 94040
      • EyePoint Investigative Site
    • Oxnard, California, United States, 93036
      • EyePoint Investigational Site
  • Florida
    • Melbourne, Florida, United States, 32901
      • EyePoint Investigational Site
    • Saint Petersburg, Florida, United States, 33711
      • EyePoint Investigational Site
  • Massachusetts
    • Springfield, Massachusetts, United States, 01107
      • EyePoint Investigational Site
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • EyePoint Investigative Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • EyePoint Investigational Site
  • Texas
    • Abilene, Texas, United States, 79606
      • EyePoint Investigational Site
    • Austin, Texas, United States, 78705
      • EyePoint Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 440 ug, single dose; EYP-1901 440 ug, single dose	Drug: EYP-1901; Intravitreal injection
Experimental: 2060 ug, single dose; EYP-1901 2060 ug, single dose	Drug: EYP-1901; Intravitreal injection
Experimental: 3090 ug, single dose; EYP-1901 3090 ug, single dose	Drug: EYP-1901; Intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)	Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in best corrected visual acuity (BCVA) by EDTRS	Mean change from Baseline in BCVA in the Study Eye	Baseline, Week 48
Mean change in central subfield thickness (CST)	Mean change from Baseline in CST measured in microns by Spectral-domain - optical coherence tomography (OCT) assessments by a study-certified OCT technician in the study eye	Baseline, Week 48

Other Outcome Measures

Outcome Measure	Time Frame
Mean change in central retinal thickness on optical coherence tomography (OCT)	Baseline, Week 48
Mean change in best corrected visual acuity (BCVA)	Baseline, Week 48

Collaborators and Investigators

• Sponsor: EyePoint Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): May 11, 2022

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: EYP-1901; EyePoint; wAMD; DAVIO
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: EYP-1901-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No