NCT05262244

Targeted Fluorescence Imaging in AMD

Targeted Fluorescence Imaging Using Bevacizumab-800CW Within Age-related Macular Degeneration (AMD) Patients to Evaluate the Upregulation of VEGF

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Rationale: To track performance of intravitreal distribution of anti-VEGF-A (Bevazicumab-800CW) and provide information about neovascularization and inflammation in Age-Related Macular Degeneration (AMD), thereby predicting progression and optimizing treatment Objective: To determine the safety and feasibility of fluorescence imaging of the eye with the fluorescent tracer bevacizumab-800CW for identification AMD with scanning laser angiography Study design: A non-randomized, non-blinded, prospective, single-center feasibility study. Study population: Patients group: patients with naïve wet AMD and wet AMD aged \>60 years old with current treatment of anti-VEGF intravitreal. Control group: patients with naïve wet AMD and wet AMD aged \>60 years old with current treatment of anti-VEGF intravitreal Intervention (if applicable): Intravenous injection of bevacizumab-800CW in the patient group. Main study parameters/endpoints: Safety and feasibility of the intravenous tracer bevacizumab-800CW in patients with naïve wet AMD and wet AMD by observing the uptake in retinal, choroid and neovascular tissue. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risk described in other (running) studies on intravenous injection with bevacizumab-800 CW. Patients need to come back 48-96 hours after injection and the eye measurements take about half an hour longer. There is no benefit with participation.

Conditions

• Age-Related Macular Degeneration
• NAMD

Interventions

Type	Name	Description
DRUG	Bevacizumab-IRDye800CW	Bevacizumab-800CW is administered to the patient and angiography is performed before and directly after tracer administration and after 48-96 hours.

Timeline

• Start date: 2022-10-28
• Primary completion: 2023-03-30
• Completion: 2024-03-30
• First posted: 2022-03-02
• Last updated: 2024-12-06

Locations

1 site across 1 country: Netherlands