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

Phase 1

Completed

• Conditions: Wet Age-related Macular Degeneration
• Interventions: Drug: EYP-1901

• Registration Number: NCT04747197
• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-10
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Status Verified: 2023-06
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
440 ug, single dose	EYP-1901	EYP-1901 440 ug, single dose
2060 ug, single dose	EYP-1901	EYP-1901 2060 ug, single dose
3090 ug, single dose	EYP-1901	EYP-1901 3090 ug, single dose

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in best corrected visual acuity (BCVA) by EDTRS	Baseline, Week 48	Mean change from Baseline in BCVA in the Study Eye
Mean change in central subfield thickness (CST)	Baseline, Week 48	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

Trial Locations

Locations (2)

EyePoint Investigative Site; 🇺🇸 Asheville, North Carolina, United States

EyePoint Investigational Site; 🇺🇸 Austin, Texas, United States