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NIR Fluorescence Molecular Imaging of ANXV-800CW in RVO Patients — SIGHT  

Retinal Vein Occlusion Clinical Trial

Official title:
Near-Infrared Fluorescence Molecular Imaging of ANXV-800CW to Visualize Its Biodistribution in the Eyes of Patients Suffering From Retinal Vein Occlusion

Clinical Trial Summary

The primary objective is safety, tolerability and feasibility of systemic intravenous injection of ANXV-800CW in patients with RVO in three dosing-cohorts in a phase I safety study. Secondary objectives are to determine in the pre-mentioned dosing-cohorts the pharmacokinetic profile of ANXV-800CW and to determine phosphatidylserine availability as measured by flow cytometry in whole blood before and after ANXV-800CW administration. Study design: non-randomized, non-blinded, prospective, mono-center safety/ feasibility dose optimization study Study population: Patients referred for (sub-)acute blurred vision with the diagnosis of RVO aged 18-85 years, fertile females excluded. Intervention: All patients will undergo a standard of care ophthalmological work-up to establish the diagnosis of RVO. In the context of this study, Fluoresceine Angiography (FA) will be added to the ophthalmological work-up for all patients. Furthermore, the patients will receive a systemic single-dose injection of ANXV-800CW as part of a optimization study, followed by NIR retinal fluorescence imaging. Main study parameters/endpoints: The main study parameters studies are safety, tolerability and feasibility of near-infrared fluorescent imaging in the retina of patients with RVO related to the systemic injection of ANXV-800CW.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05133791
Study type Interventional
Source University Medical Center Groningen
Contact Yester Janssen, MD
Phone +31615170900
Email y.f.janssen@umcg.nl
Status Recruiting
Phase Phase 1
Start date September 23, 2021
Completion date May 1, 2024
View Details
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