NCT05262244CompletedPhase 1
Targeted Fluorescence Imaging in AMD
Targeted Fluorescence Imaging Using Bevacizumab-800CW Within Age-related Macular Degeneration (AMD) Patients to Evaluate the Upregulation of VEGF
Source: ClinicalTrials.gov · Last updated 6 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 19 Nov 2021
- Start date
- 28 Oct 2022
- Primary completion date
- 30 Mar 2023
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Macular degeneration
- NCT number
- NCT05262244
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 28 Oct 2022 to the primary completion date, 30 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent uncontrolled medical conditions;
- Received a different investigational drug within 30 days prior to the dose of bevacizumab-800CW;
Other illness
- Patients with psychological diseases or medical issues who are not able to sign informed consent form;
- History of infusion reactions to bevacizumab or other monoclonal antibody.
Other
- Eye pathology interfering with retinal imaging;
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen (UMCG) Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
Related publications
- Targeted Fluorescence Imaging of Bevacizumab-800CW in Patients with Neovascular Age-Related Macular Degeneration.J Nucl Med · 2026 · PMID 41344859
This page is information, not medical advice. Discuss any trial with your doctor.