Targeted Fluorescence Imaging in AMD (LEAF)

University Medical Center Groningen (UMCG)

Status and phase

Completed

Phase 1

Conditions

NAMD

Age-Related Macular Degeneration

Treatments

Drug: Bevacizumab-IRDye800CW

Study type

Interventional

Funder types

Other

Identifiers

NCT05262244

NL78391.056.21

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.