Neovascular Age-Related Macular DegenerationRAZORBILLNCT04662944
A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections
An observational study of Neovascular Age-Related Macular Degeneration, run by Novartis Pharmaceuticals at 17 sites in 5 countries.
Trial summary
RAZORBILL was an observational, multicenter, multinational, open-label, study designed primarily to investigate the influence of automated OCT image enrichment with segmentation information on disease activity assessment in nAMD patients treated with licensed anti-VEGFs Read more about this study
- Who is it for?
- Ages 18 to 199 years
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- What is being tested?
- brolucizumab, ranibizumab and aflibercept
- How many people
- 494 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 23 Feb 2021to 28 Jun 2023
- Phase
- Observational
- 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 18 to 199 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.
Who may be able to join
- Diagnosis of nAMD
- Male and Female patients with ≥18 years of age at index
- Receipt of at least one injection of brolucizumab, ranibizumab or aflibercept during the recruitment period
- Signed written informed consent
- Patients for whom a therapy with brolucizumab, ranibizumab or aflibercept is medically indicated according to the respective label
- Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at screening
Who cannot join
- Patients treated for any other retinal disease than nAMD within 6 months prior to the index date (e.g. patients treated for retinal vein occlusion, diabetic macular oedema, myopic CNV, and have diagnoses of diabetes-related macular degeneration)
- Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis >50% of the total lesion in the study eye at screening
- Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
- Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
- Patients who have any contraindication and are not eligible for treatment with the chosen anti-VEGF treatment as according to the respective label.
- Any medical or psychological condition, in the treating physician's opinion, which may hinder the patient from participating in this study for the expected 12 months
- Patients participating, in parallel, in an interventional clinical trial
- Patients participating, in parallel, in any other Novartis sponsored NIS generating primary data for an anti-VEGF drug
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Germany6 sites
Novartis Investigative Site
Bonn, 53105
Novartis Investigative Site
Düsseldorf, 40212
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Ludwigsburg, Baden-Wurttemberg, 71638
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Ulm, 89075
Spain4 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Bormujos, Sevilla, 41930
Novartis Investigative Site
León, 24080
Canada3 sites
Novartis Investigative Site
Hamilton, Ontario, L8G 5E4
Novartis Investigative Site
Montreal, Quebec, H1V 1G5
Novartis Investigative Site
Toronto, Ontario, M8X 2X3
Ireland2 sites
Novartis Investigative Site
Glasnevin, Dublin 9, D09 YN97
Novartis Investigative Site
Waterford, 48327
Italy2 sites
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Milan, MI, 20157
About this study
Official title: A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography (OCT) Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections
RAZORBILL was an observational, multicenter, multinational, open-label, study designed primarily to investigate the influence of automated OCT image enrichment with segmentation information on disease activity assessment in nAMD patients treated with licensed anti-VEGFs
Read the detailed description
The main goal of this study was to assess to what degree disease activity assessment is influenced and supported by the enrichment of OCT images with segmentation information (i.e. by identification, highlighting and quantification of pathological fluid compartments associated with neovascular activity).
The study comprised a prospective data collection phase and a retrospective analysis of OCT images phase. The prospective observation period per patient was up to 12 months.
The study included patients (naïve patients and patients who had been pre-treated with licensed anti-VEGFs not more than 3 years) being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.
- Being tested
- brolucizumab, ranibizumab, aflibercept
- Keywords
- nAMD, Neovascular Age-Related Macular Degeneration, anti-VEGF, RAZORBILL, optical coherence tomography, OCT, Artificial Intelligence, Machine learning, Automatic OCT segmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brolucizumabDrug
There was no treatment allocation. Patients administered Brolucizumab by prescription that started before inclusion of the patient into the study were enrolled.
ranibizumabDrug
There was no treatment allocation. Patients administered Ranibizumab by prescription that started before inclusion of the patient into the study were enrolled.
afliberceptDrug
There was no treatment allocation. Patients administered Aflibercept by prescription that started before inclusion of the patient into the study were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Licensed anti-VEGFs | Patients being treated for nAMD with licensed anti-VEGFs Receives: Drug: brolucizumab; Drug: ranibizumab; Drug: aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds ratio of disease activity assessment from Optical Coherence Tomography (OCTs) with and without enrichment
An odds ratio of disease activity assessment from OCTs with and without enrichment was reported with a 95% confidence interval.
Measured: 12 months
Degree of agreement in classification of disease activity using enriched and non-enriched OCT images
Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using OCT images
Measured: 12 months
Secondary outcomes (8)
Difference in time needed for Disease Activity Assessment (DAA) between reviews with and without enrichment
the difference in time to DAA (time between begin of OCT viewing and result sub-mission) between cases reviewed with and without use of segmentation information was calculated.
Measured: 12 months
Difference in confidence in DAA between reviews with and without enrichment
difference in confidence in DAA between cases reviewed with and without enrichment (rating of 1-10 per case, whereby a rating of 10 meant maximal confidence) was calculated
Measured: 12 months
Acceptance of Discovery by physicians and whether it can optimize the ophthalmic clinical workflow
Physicians used a digital solution Discovery for managing imaging data and automatic segmentation of OCT volumes. To understand if such a tool is well suited for its role in its current form, holds value for physicians and can optimize clinical workflow, physicians were invited to complete questionnaires regarding their user experience.
Measured: Month 12
Percentage of patients with absence of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment
Percentage of patients with absence of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment was provided
Measured: Month 12
Central Subfield Thickness (CST) change
Course of Central Subfield Thickness (CST) change was provided
Measured: 12 months
Best-corrected visual acuity change from baseline
Best-corrected visual acuity change from baseline was provided
Measured: 12 months
Percentage of patients with ocular and non-ocular adverse events
Percentage of patients with ocular and non-ocular adverse events was provided
Measured: 12 months
Subjective assessment of system correctness
Investigators assessed the correctness of the system on a scale from 0 to 10 (10 corresponds to maximum correctness) if segmentation algorithm was used.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start23 Feb 2021
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
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 Neovascular Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662944
- Sponsor's protocol ID
- CRTH258A2402
- Acronym
- RAZORBILL
- Status last verified
- Jun 2024
- First submitted
- 24 Nov 2020
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kortuem KU, Zarranz-Ventura J, Bandello F, Duval R, O'Toole L, De Zanet S, Blair JPM, Seaman J, Zvolanek M, Jaeger K, Gmeiner B, Holz FG. Impact of AI-enhanced three-dimensional OCT scans on disease activity assessment in patients with nAMD: the RAZORBILL study. Br J Ophthalmol. 2026 May 4:bjo-2024-327060. doi: 10.1136/bjo-2024-327060. Online ahead of print.
PubMed 42082322
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography (OCT) Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections
- ClinicalTrials.gov ID
- NCT04662944
- Acronym / sponsor ID
- RAZORBILL / CRTH258A2402
- Keywords
- nAMD, Neovascular Age-Related Macular Degeneration, anti-VEGF, RAZORBILL, optical coherence tomography, OCT, Artificial Intelligence, Machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 10 Dec 2020 (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.
RAZORBILL was an observational, multicenter, multinational, open-label, study designed primarily to investigate the influence of automated OCT image enrichment with segmentation information on disease activity assessment in nAMD patients treated with licensed anti-VEGFs
Detailed description
The main goal of this study was to assess to what degree disease activity assessment is influenced and supported by the enrichment of OCT images with segmentation information (i.e. by identification, highlighting and quantification of pathological fluid compartments associated with neovascular activity).
The study comprised a prospective data collection phase and a retrospective analysis of OCT images phase. The prospective observation period per patient was up to 12 months.
The study included patients (naïve patients and patients who had been pre-treated with licensed anti-VEGFs not more than 3 years) being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Licensed anti-VEGFs | – | Drug: brolucizumab, Drug: ranibizumab, Drug: afliberceptPatients being treated for nAMD with licensed anti-VEGFs |
Who may qualify
- Ages
- 18 to 199 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.
Key inclusion criteria (6 listed)
- Diagnosis of nAMD
- Male and Female patients with ≥18 years of age at index
- Receipt of at least one injection of brolucizumab, ranibizumab or aflibercept during the recruitment period
- Signed written informed consent
- Patients for whom a therapy with brolucizumab, ranibizumab or aflibercept is medically indicated according to the respective label
Key exclusion criteria (8 listed)
- Patients treated for any other retinal disease than nAMD within 6 months prior to the index date (e.g. patients treated for retinal vein occlusion, diabetic macular oedema, myopic CNV, and have diagnoses of diabetes-related macular degeneration)
- Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis >50% of the total lesion in the study eye at screening
- Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
- Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
- Patients who have any contraindication and are not eligible for treatment with the chosen anti-VEGF treatment as according to the respective label.
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 |
|---|---|---|
| brolucizumabThere was no treatment allocation. Patients administered Brolucizumab by prescription that started before inclusion of the patient into the study were enrolled. | Drug | Licensed anti-VEGFs |
| ranibizumabThere was no treatment allocation. Patients administered Ranibizumab by prescription that started before inclusion of the patient into the study were enrolled. | Drug | Licensed anti-VEGFs |
| afliberceptThere was no treatment allocation. Patients administered Aflibercept by prescription that started before inclusion of the patient into the study were enrolled. | Drug | Licensed anti-VEGFs |
Primary outcome
Odds ratio of disease activity assessment from Optical Coherence Tomography (OCTs) with and without enrichment
Time frame: 12 months
An odds ratio of disease activity assessment from OCTs with and without enrichment was reported with a 95% confidence interval.
Degree of agreement in classification of disease activity using enriched and non-enriched OCT images
Time frame: 12 months
Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using OCT images
8 secondary outcomes
Difference in time needed for Disease Activity Assessment (DAA) between reviews with and without enrichment
Time frame: 12 months
Difference in confidence in DAA between reviews with and without enrichment
Time frame: 12 months
Acceptance of Discovery by physicians and whether it can optimize the ophthalmic clinical workflow
Time frame: Month 12
Percentage of patients with absence of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment
Time frame: Month 12
Central Subfield Thickness (CST) change
Time frame: 12 months
Best-corrected visual acuity change from baseline
Time frame: 12 months
Percentage of patients with ocular and non-ocular adverse events
Time frame: 12 months
Subjective assessment of system correctness
Time frame: 12 months
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 18 Jun 2024.
- Derived from this study: PubMed 42082322Kortuem KU, Zarranz-Ventura J, Bandello F, Duval R, O'Toole L, De Zanet S, Blair JPM, Seaman J, Zvolanek M, Jaeger K, Gmeiner B, Holz FG. Impact of AI-enhanced three-dimensional OCT scans on disease activity assessment in patients with nAMD: the RAZORBILL study. Br J Ophthalmol. 2026 May 4:bjo-2024-327060. doi: 10.1136/bjo-2024-327060. Online ahead of print.
- Results for CRTH258A2402 that is getting linked from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-Related Macular Degeneration, run by Novartis Pharmaceuticals at 17 sites in 5 countries.
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 6 inclusion and 8 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 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Spain, Canada, Ireland, Italy. 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.
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?
Odds ratio of disease activity assessment from Optical Coherence Tomography (OCTs) with and without enrichment (time frame: 12 months). 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 NCT04662944, 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 18 Jun 2024.