Targeted fluorescence imaging using bevacizumab-800CW within Age-related Macular Degeneration (AMD) patients to evaluate the upregulation of VEGF

Recruiting

Conditions: 10047060
age related macula degeneration

Registration Number: NL-OMON52066

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 24

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The measured fluorescence intensity by observing the uptake in retinal, choroid<br /><br>and neovascular tissue.<br /><br>Safety evaluation of vital parameters, adverse events (AE), serious adverse<br /><br>events (SAE) and suspected unexpected serious adverse reactions (SUSAR);</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• The optimal dose of bevacizumab-800CW in AMD patients<br /><br>• The correlation between the fluorescence intensity, target-to-background<br /><br>ratio (TBR) and the disease subtype and severity.<br /><br>• The difference in uptake between bevacizumab-800CW and vedolizumab-800CW.<br /><br>• The correlation between the VEGF expression within the tear and the<br /><br>fluorescence signal</p><br>