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OpenTrials
Completed

NCT Number: NCT04747197

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

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)

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

EyePoint Investigational Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EYP-1901

Drug

Intravitreal injection

Primary outcomes

  1. Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)

    Time frame: Week 48

    Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population

Secondary outcomes

  1. Change in best corrected visual acuity (BCVA) by EDTRS

    Time frame: Baseline, Week 48

    Mean change from Baseline in BCVA in the Study Eye

  2. Mean change in central subfield thickness (CST)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

EyePoint Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2021
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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