A Phase 1, Open-Label, Dose-Escalation Trial to Investigate Safety and Tolerability of Single Intravitreous Injections of ICON-1 Targeting Tissue Factor in Wet AMD

Ophthalmic Surgery, Lasers & Imaging Retina
John A WellsGabriela Burian

Abstract

This phase 1 study evaluated the safety and tolerability of single intravitreous injections (IVIs) of ICON-1 (Iconic Therapeutics, South San Francisco, CA) in patients with neovascular age-related macular degeneration (nAMD). ICON-1 is a modified factor VIIa protein linked with the Fc portion of a human immunoglobulin G1. The molecule binds tissue factor overexpressed on choroidal neovascularization (CNV) in AMD. Open-label, interventional, dose-escalation trial in 18 patients with CNV due to AMD, with six patients per dose cohort. Patients received a single IVI of ICON-1 at baseline in one of three escalating doses: 60 μg, 150 μg, or 300 μg. Standard anti-vascular endothelial growth factor treatment was allowed at the investigator's discretion at least 2 weeks after the ICON-1 injection; patients were followed up to 24 weeks. Dose escalation was based on the absence of significant safety events. At each study visit, best-corrected visual acuity (BCVA), ophthalmic examination (intraocular pressure, slit-lamp, and dilated fundus examination), and ophthalmic imaging (color fundus photography, fluorescein angiography, and optical coherence tomography) assessments were performed. The systemic pharmacokinetics of ICON-1 and presence...Continue Reading

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Citations

Sep 21, 2018·Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics·Gary D Novack
Jun 9, 2020·Asia-Pacific Journal of Ophthalmology·Anindya SamantaJay Chhablani
Mar 6, 2019·The Cochrane Database of Systematic Reviews·Sharon D SolomonBarbara S Hawkins
Oct 3, 2021·International Journal of Retina and Vitreous·Sruthi Arepalli, Peter K Kaiser
Oct 17, 2021·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Mariacristina ParravanoGianni Virgili
Nov 2, 2021·Advances in Therapy·Dionysis D BalatsoukasFotis Topouzis

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