NIR Fluorescence Molecular Imaging of ANXV-800CW in RVO Patients
Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
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.