Age-Related Macular DegenerationPhase 1LEAFNCT05262244
Targeted Fluorescence Imaging in AMD
A Phase 1 study testing Bevacizumab-IRDye800CW in people with Age-Related Macular Degeneration and NAMD, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, NAMD
- What is being tested?
- Bevacizumab-IRDye800CW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Oct 2022to 30 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University medical center Groningen (UMCG)
Groningen, Provincie Groningen, 9713 GZ
About this study
Official title: Targeted Fluorescence Imaging Using Bevacizumab-800CW Within Age-related Macular Degeneration (AMD) Patients to Evaluate the Upregulation of VEGF
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
Read more
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.
- Conditions
- Age-Related Macular Degeneration, NAMD
- Being tested
- Bevacizumab-IRDye800CW
- Keywords
- fluorescence, ophthalmology, bevacizumab-800CW, nAMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab-IRDye800CWDrug
Bevacizumab-800CW is administered to the patient and angiography is performed before and directly after tracer administration and after 48-96 hours.
| Study group | Role | What they receive |
|---|---|---|
| AMD with bevacizumab-800CW | Experimental | Patients with AMD receive bevacizumab-800CW followed by angiography Receives: Drug: Bevacizumab-IRDye800CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Directly after administration until 96 hours after.
Feasibility: the possibility of measuring the specific uptake of fluorescence within the eye using both scanning laser angiography and optical coherence tomography.
The target-to-background radio will be measured during fluorescence imaging and compared with imaging before tracer administration.
Measured: Directly after administration until 96 hours after
Secondary outcomes (4)
Determination of the most optimal dose of bevacizumab-800CW for fluorescence imaging of the eye vascularization.
The target-to-background radio will be calculated and the dose with the highest ratio will be used as most optimal dose.
Measured: Directly after administration until 96 hours after.
Correlation of the fluorescence intensity, target-to-background ratio (TBR), with disease identification
The target-to-background ratio will be calculated and compared to the disease identification scale.
Measured: Up to 1 year
Correlation between fluorescence intensity and clinical score
The subtype and severity of neovascularization will be determined and used as a clinical score.
Measured: Up to 1 year
Correlation of VEGF expression within the tear fluid with the fluorescent signal
Gather tear fluid with Schirmer strips and using ELISA to extract the VEGF concentration and correlate this with the fluorescence signal
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start28 Oct 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- W. B Nagengast, MD, PhD, PharmD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262244
- Sponsor's protocol ID
- NL78391.056.21
- Acronym
- LEAF
- Status last verified
- Mar 2023
- First submitted
- 19 Nov 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmidt I, Volkmer P, Muskens RPHM, van der Waaij AM, van Dam GM, Huiskamp EA, Nagengast WB. Targeted Fluorescence Imaging of Bevacizumab-800CW in Patients with Neovascular Age-Related Macular Degeneration. J Nucl Med. 2026 Jan 2;67(1):119-125. doi: 10.2967/jnumed.125.270802.
PubMed 41344859
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Fluorescence Imaging Using Bevacizumab-800CW Within Age-related Macular Degeneration (AMD) Patients to Evaluate the Upregulation of VEGF
- ClinicalTrials.gov ID
- NCT05262244
- Acronym / sponsor ID
- LEAF / NL78391.056.21
- Conditions
- Age-Related Macular Degeneration, NAMD
- Keywords
- fluorescence, ophthalmology, bevacizumab-800CW, nAMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| AMD with bevacizumab-800CW | Experimental | Drug: Bevacizumab-IRDye800CWPatients with AMD receive bevacizumab-800CW followed by angiography |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab-IRDye800CWBevacizumab-800CW is administered to the patient and angiography is performed before and directly after tracer administration and after 48-96 hours. | Drug | AMD with bevacizumab-800CW |
Primary outcome
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
Time frame: 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.
Time frame: 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.
4 secondary outcomes
Determination of the most optimal dose of bevacizumab-800CW for fluorescence imaging of the eye vascularization.
Time frame: Directly after administration until 96 hours after.
Correlation of the fluorescence intensity, target-to-background ratio (TBR), with disease identification
Time frame: Up to 1 year
Correlation between fluorescence intensity and clinical score
Time frame: Up to 1 year
Correlation of VEGF expression within the tear fluid with the fluorescent signal
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 41344859Schmidt I, Volkmer P, Muskens RPHM, van der Waaij AM, van Dam GM, Huiskamp EA, Nagengast WB. Targeted Fluorescence Imaging of Bevacizumab-800CW in Patients with Neovascular Age-Related Macular Degeneration. J Nucl Med. 2026 Jan 2;67(1):119-125. doi: 10.2967/jnumed.125.270802.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. B Nagengast, MD, PhD, PharmD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bevacizumab-IRDye800CW in people with Age-Related Macular Degeneration and NAMD, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Directly after administration until 96 hours after.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05262244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.