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Targeted Fluorescence Imaging in AMD

NCT ID: NCT05262244

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-28

Study Completion Date

2024-03-30

Brief Summary

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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

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Conditions

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Age-Related Macular Degeneration NAMD

Keywords

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fluorescence, ophthalmology, bevacizumab-800CW, nAMD

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AMD with bevacizumab-800CW

Patients with AMD receive bevacizumab-800CW followed by angiography

Group Type EXPERIMENTAL

Bevacizumab-IRDye800CW

Intervention Type DRUG

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

Interventions

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Bevacizumab-IRDye800CW

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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W. B Nagengast, MD, PhD, PharmD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University medical center Groningen (UMCG)

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL78391.056.21

Identifier Type: -

Identifier Source: org_study_id