Targeted Fluorescence Imaging in AMD

NCT05262244 | Completed Phase 1 DMC

• 1 other identifier: NL78391.056.21
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration; NAMD

Keywords

fluorescence, ophthalmology, bevacizumab-800CW, nAMD

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

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

  Directly after administration until 96 hours after.

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

  Up to 1 year

• Correlation between fluorescence intensity and clinical score

  Up to 1 year

• Correlation of VEGF expression within the tear fluid with the fluorescent signal

  Up to 1 year

Study Arms (1)

AMD with bevacizumab-800CW

EXPERIMENTAL

Patients with AMD receive bevacizumab-800CW followed by angiography

Drug: Bevacizumab-IRDye800CW

Interventions

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.

AMD with bevacizumab-800CW

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University medical center Groningen (UMCG)

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• W. B Nagengast, MD, PhD, PharmD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: First a dose finding study is performed using bevacizumab-800CW within the AMD patient group. Using the optimal dose and if fluorescence is visible, additional inclusion of patients with the optimal dose.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: March 2, 2022
• Study Start: October 28, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)