To determine the safety and feasibility of fluorescence imaging of the eye vascularization with the fluorescent tracer bevacizumab-800CW for identification of neovascular Age-related Macular Degeneration (AMD) with scanning laser angiography.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The measured fluorescence intensity by observing the uptake in retinal, choroid
and neovascular tissue.
Safety evaluation of vital parameters, adverse events (AE), serious adverse
events (SAE) and suspected unexpected serious adverse reactions (SUSAR);
Secondary outcome
• The optimal dose of bevacizumab-800CW in AMD patients
• The correlation between the fluorescence intensity, target-to-background
ratio (TBR) and the disease subtype and severity.
• The difference in uptake between bevacizumab-800CW and vedolizumab-800CW.
• The correlation between the VEGF expression within the tear and the
fluorescence signal
Background summary
Age-related Macular Degeneration (AMD) is an eye disease that destroys the
macula, the part of the eye that provides sharp, central vision. It is the
third leading cause of blindness. 'Dry' AMD is the most common form, but we are
mainly interested in 'wet' AMD. In this type overexpression of VEGF-A causes
neovascularization and thereby progression of the disease. These patients are
treated with intravitreal anti-VEGF-A injections, though progression is still
observed.
With injection of the fluorescent tracer bevacizumab-800 CW (anti-VEGF-A) we
might enable a better understanding of the pathophysiology of VEGF mediated
retinal diseases and response to anti-VEGF therapy.
Study objective
To determine the safety and feasibility of fluorescence imaging of the eye
vascularization with the fluorescent tracer bevacizumab-800CW for
identification of neovascular Age-related Macular Degeneration (AMD) with
scanning laser angiography.
Study design
The current study is a non-randomized, non-blinded, prospective, single-center
feasibility study.
For the AMD-Bevacizumab two times six patients will be included who receive
either 4.5 or 15 mg bevacizumab-800CW. After inclusion of these first twelve
patients, an interim analysis will be performed to determine the
target-to-background (TBR) in the in vivo images. After the interim analysis,
either the 4.5 or 15 mg group will be extended to a maximum of 12 patients. If
no fluorescence is detected, the study will be closed after the interim
analysis.
Additionally, two types of control groups are added. A tracer control group and
a disease control group. The first includes patients with neovascular AMD
receiving vedolizumab-800CW to verify the specific binding of the tracer. The
latter, includes a group of patients who already receives the tracer
bevacizumab-800CW but do not have AMD, to verify difference in signal between
disease and no-disease. The AMD-Vedolizumab group will consist of six patients
receiving only the optimal doses which is established after the interim
analysis.
All patients receive standard clinical care followed by study measurements.
Patients will receive an extra OCT and fluorescence measurements before, during
and until 1 hour after tracer administration. Patients with AMD (both
vedolizumab and bevacizumab) will have an additional measurement at 48-96 hours
after administration.
Intervention
Patients receive either bevacizumab-800CW or vedolizumab-800CW. On day 0 they
receive both a clinical angiography and a study-related angiography.
Additionally, after 48-72 hours a second study-related angiography is
performed.
Study burden and risks
No additional risks are expected as previously performed studies with the
tracers bevacizumab and vedolizumab-800CW did not show any risks. There is some
extra time investment of the patient of 4 hours when joining this research.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
4.2 Inclusion criteria (Patient population)
• Patients with naïve neovascular AMD or neovascular AMD suspected of active
disease
• Aged >60years old
• Patients can be included if they already receive therapeutic bevacizumab
injections for AMD.
Inclusion criteria (Control population)
• Patients with naïve neovascular AMD or neovascular AMD suspected of active
disease
• >60 years of age
- Patients can be included if they already receive therapeutic bevacizumab
injections for AMD.
Exclusion criteria
4.3 Exclusion criteria (both populations)
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-003726-74-NL |
| ClinicalTrials.gov | NCT05262244 |
| CCMO | NL78391.056.22 |