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Completed

NCT Number: NCT05262244

Targeted Fluorescence Imaging in AMD

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases nAMD

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University medical center Groningen (UMCG)

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab-IRDye800CW

Drug

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

Primary outcomes

  1. 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

    Time frame: 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.

  2. Feasibility: the possibility of measuring the specific uptake of fluorescence within the eye using both scanning laser angiography and optical coherence tomography.

    Time frame: 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.

Secondary outcomes

  1. Determination of the most optimal dose of bevacizumab-800CW for fluorescence imaging of the eye vascularization.

    Time frame: 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.

  2. Correlation of the fluorescence intensity, target-to-background ratio (TBR), with disease identification

    Time frame: Up to 1 year

    The target-to-background ratio will be calculated and compared to the disease identification scale.

  3. Correlation between fluorescence intensity and clinical score

    Time frame: Up to 1 year

    The subtype and severity of neovascularization will be determined and used as a clinical score.

  4. Correlation of VEGF expression within the tear fluid with the fluorescent signal

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: LEAF

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 2, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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