NCT05133791

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Annexin A5	Annexin A5 coupled to IRDye800CW as a potential treatment for RVO

Timeline

• Start date: 2021-09-23
• Primary completion: 2024-01-01
• Completion: 2024-05-01
• First posted: 2021-11-24
• Last updated: 2023-08-31

Locations

1 site across 1 country: Netherlands