Clinical trial NCT05262244: Targeted Fluorescence Imaging in AMD
Official title: Targeted Fluorescence Imaging Using Bevacizumab-800CW Within Age-related Macular Degeneration (AMD) Patients to Evaluate the Upregulation of VEGF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age-Related Macular Degeneration
NAMD
Keywords: fluorescence, ophthalmology, bevacizumab-800CW, nAMD
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 12
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Directly after administration until 96 hours after.
measure: Feasibility: the possibility of measuring the specific uptake of fluorescence within the eye using both scanning laser angiography and optical coherence tomography.
timeFrame: Directly after administration until 96 hours after
Secondary outcomes:
measure: Determination of the most optimal dose of bevacizumab-800CW for fluorescence imaging of the eye vascularization.
timeFrame: Directly after administration until 96 hours after.
measure: Correlation of the fluorescence intensity, target-to-background ratio (TBR), with disease identification
timeFrame: Up to 1 year
measure: Correlation between fluorescence intensity and clinical score
timeFrame: Up to 1 year
measure: Correlation of VEGF expression within the tear fluid with the fluorescent signal
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University medical center Groningen (UMCG)
Study officials:
affiliation: University Medical Center Groningen
name: W. B Nagengast, MD, PhD, PharmD
role: PRINCIPAL_INVESTIGATOR
References: