Targeted Fluorescence Imaging in AMD

Age-Related Macular Degeneration Clinical Trial

— LEAF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05262244
• Other study ID #: NL78391.056.21
• Status: Recruiting
• Phase: Phase 1
• Start date: October 28, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: University Medical Center Groningen
• Contact: W B Nagengast, MD, PhD, PharmD
• Phone: +31503612620
• Email: w.b.nagengast[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and vedolizumab-800CW in the control 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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.
• Vedolizumab-IRDye800CW
Vedolizumab-800CW is administered to the patient and angiography is performed before and directly after tracer administration and after 48-96 hours.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Directly after administration until 96 hours after.
Primary	Feasibility: the possibility of measuring the specific uptake of fluorescence within the eye using both scanning laser angiography and optical coherence tomography.	The target-to-background radio will be measured during fluorescence imaging and compared with imaging before tracer administration.	Directly after administration until 96 hours after
Secondary	Determination of the most optimal dose of bevacizumab-800CW for fluorescence imaging of the eye vascularization.	The target-to-background radio will be calculated and the dose with the highest ratio will be used as most optimal dose.	Directly after administration until 96 hours after.
Secondary	Correlation of the fluorescence intensity, target-to-background ratio (TBR), with disease identification	The target-to-background ratio will be calculated and compared to the disease identification scale.	Up to 1 year
Secondary	Verification the specific uptake of bevazicumab-800CW by comparing the target-to-background ratio to the control antibody vedolizumab-800CW	The target-to-background of bevacizumab-800CW and vedolizumab-800CW will be compared.	Up to 1 year
Secondary	Correlation between fluorescence intensity and clinical score	The subtype and severity of neovascularization will be determined and used as a clinical score.	Up to 1 year
Secondary	Correlation of VEGF expression within the tear fluid with the fluorescent signal	Gather tear fluid with Schirmer strips and using ELISA to extract the VEGF concentration and correlate this with the fluorescence signal	Up to 1 year