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

Wet Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747197
• Other study ID #: EYP-1901-001
• Status: Completed
• Phase: Phase 1
• Start date: January 20, 2021
• Est. completion date: May 11, 2022

Study information

• Verified date: June 2023
• Source: EyePoint Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

Drug:
• EYP-1901
Intravitreal injection

Locations

Country	Name	City	State
United States	EyePoint Investigational Site	Abilene	Texas
United States	EyePoint Investigative Site	Asheville	North Carolina
United States	EyePoint Investigational Site	Austin	Texas
United States	EyePoint Investigational Site	Beverly Hills	California
United States	EyePoint Investigational Site	Melbourne	Florida
United States	EyePoint Investigative Site	Mountain View	California
United States	EyePoint Investigational Site	Oxnard	California
United States	EyePoint Investigational Site	Philadelphia	Pennsylvania
United States	EyePoint Investigational Site	Phoenix	Arizona
United States	EyePoint Investigational Site	Saint Petersburg	Florida
United States	EyePoint Investigational Site	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EyePoint Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in best corrected visual acuity (BCVA) by EDTRS	Mean change from Baseline in BCVA in the Study Eye	Baseline, Week 48
Secondary	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