Targeted Fluorescence Imaging in AMD

Phase 1

Completed

• Conditions: Age-Related Macular Degeneration; NAMD
• Interventions: Drug: Bevacizumab-IRDye800CW

• Registration Number: NCT05262244
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-02
• Study Start: 2022-10-28
• Status Verified: 2023-03
• Primary Completion: 2023-03-30
• Study Completion: 2024-03-30
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients with either naïve wet AMD or wet AMD receiving standard care of anti-VEGF therapy
• Aged >60 years old

Optional: Patients already included in fluorescence study which involves Bevacizumab-800CW

Exclusion Criteria

• Eye pathology interfering with retinal imaging;
• Patients with psychological diseases or medical issues who are not able to sign informed consent form;
• Concurrent uncontrolled medical conditions;
• Received a different investigational drug within 30 days prior to the dose of bevacizumab-800CW;
• History of infusion reactions to bevacizumab or other monoclonal antibody.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
AMD with bevacizumab-800CW	Bevacizumab-IRDye800CW	Patients with AMD receive bevacizumab-800CW followed by angiography

Primary Outcome Measures

Name	Time	Method
Feasibility: the possibility of measuring the specific uptake of fluorescence within the eye using both scanning laser angiography and optical coherence tomography.	Directly after administration until 96 hours after	The target-to-background radio will be measured during fluorescence imaging and compared with imaging before tracer administration.
Safety: number of participants with symptoms or changes in vital signs (blood pressure, heart rate and temperature) that are related to administration of bevacizumab-800CW	Directly after administration until 96 hours after.	To determine the safety of bevacizumab-800CW in patients with AMD by monitoring of vital signs (blood pressure, heart rate and temperature), before and until one hour after administration.

Secondary Outcome Measures

Name	Time	Method
Determination of the most optimal dose of bevacizumab-800CW for fluorescence imaging of the eye vascularization.	Directly after administration until 96 hours after.	The target-to-background radio will be calculated and the dose with the highest ratio will be used as most optimal dose.
Correlation of the fluorescence intensity, target-to-background ratio (TBR), with disease identification	Up to 1 year	The target-to-background ratio will be calculated and compared to the disease identification scale.
Correlation between fluorescence intensity and clinical score	Up to 1 year	The subtype and severity of neovascularization will be determined and used as a clinical score.
Correlation of VEGF expression within the tear fluid with the fluorescent signal	Up to 1 year	Gather tear fluid with Schirmer strips and using ELISA to extract the VEGF concentration and correlate this with the fluorescence signal

Trial Locations

Locations (1)

University medical center Groningen (UMCG); 🇳🇱 Groningen, Netherlands