LEAF: Targeted Fluorescence Imaging in AMD
Study Details
Study Description
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 >60years 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 Optional control group: patients without eye disease and currently included in another bevacizumab-800CW study.
Intervention (if applicable):
Intravenous injection of bevacizumab-800CW in the patient group and vedolizumab-800CW in the control 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 48-72 hours after injection and the eye measurements take about half an hour longer.
There is no benefit with participation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: AMD with bevacizumab-800CW Patients with AMD receive bevacizumab-800CW followed by angiography |
Drug: Bevacizumab-IRDye800CW
Bevacizumab-800CW is administered to the patient and angiography is performed before and directly after tracer administration and after 48-72 hours.
|
| Placebo Comparator: AMD with vedolizumab-800CW Patients with AMD receive vedolizumab-800CW followed by angiography |
Drug: Vedolizumab-IRDye800CW
Vedolizumab-800CW is administered to the patient and angiography is performed before and directly after tracer administration and after 48-72 hours.
|
| Other: Healthy patients with bevacizumab-800CW Healthy patients, included in fluorescence cancer study receiving bevacizumab-800CW, receive an angiography. |
Drug: Bevacizumab-IRDye800CW
Bevacizumab-800CW is administered to healthy patients which receive bevacizumab-800CW for cancer research. These patients also receive an angiography before and directly after tracer administration and after 48-72 hours.
|
Outcome Measures
Primary Outcome Measures
- 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 72 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 72 hours after]
The target-to-background radio will be measured during fluorescence imaging and compared with imaging before tracer administration.
Secondary Outcome Measures
- Determination of the most optimal dose of bevacizumab-800CW for fluorescence imaging of the eye vascularization. [Directly after administration until 72 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]
- Verification the specific uptake of bevazicumab-800CW by comparing the target-to-background ratio to the control antibody vedolizumab-800CW [Up to 1 year]
The target-to-background of bevacizumab-800CW and vedolizumab-800CW will be compared.
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Medical Center Groningen
Investigators
- Principal Investigator: W. B Nagengast, MD, PhD, PharmD, University Medical Center Groningen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL78391.056.21