Age-Related Macular Degeneration, NAMD
Conditions
Keywords
fluorescence, ophthalmology, bevacizumab-800CW, nAMD
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.
Interventions
Bevacizumab-800CW is administered to the patient and angiography is performed before and directly after tracer administration and after 48-96 hours.
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Feasibility: the possibility of measuring the specific uptake of fluorescence within the eye using both scanning laser angiography and optical coherence tomography. | 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
| Measure | Time frame | Description |
|---|---|---|
| Determination of the most optimal dose of bevacizumab-800CW for fluorescence imaging of the eye vascularization. | 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. |
| Correlation of the fluorescence intensity, target-to-background ratio (TBR), with disease identification | Up to 1 year | The target-to-background ratio will be calculated and compared to the disease identification scale. |
| Correlation between fluorescence intensity and clinical score | Up to 1 year | The subtype and severity of neovascularization will be determined and used as a clinical score. |
| Correlation of VEGF expression within the tear fluid with the fluorescent signal | 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 |
Countries
Netherlands
Outcome results
None listed