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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Bevacizumab-800CW is administered to the patient and angiography is performed before and directly after tracer administration and after 48-96 hours.
University medical center Groningen (UMCG)
Groningen, Provincie Groningen, Netherlands
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.
Time frame: 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.
Time frame: Directly after administration until 96 hours after
Determination of the most optimal dose of bevacizumab-800CW for fluorescence imaging of the eye vascularization.
The target-to-background radio will be calculated and the dose with the highest ratio will be used as most optimal dose.
Time frame: Directly after administration until 96 hours after.
Correlation of the fluorescence intensity, target-to-background ratio (TBR), with disease identification
The target-to-background ratio will be calculated and compared to the disease identification scale.
Time frame: Up to 1 year
Correlation between fluorescence intensity and clinical score
The subtype and severity of neovascularization will be determined and used as a clinical score.
Time frame: Up to 1 year
Correlation of VEGF expression within the tear fluid with the fluorescent signal
Gather tear fluid with Schirmer strips and using ELISA to extract the VEGF concentration and correlate this with the fluorescence signal
Time frame: Up to 1 year
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