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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Licensed anti-VEGFs | Patients being treated for nAMD with licensed anti-VEGFs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brolucizumab | Drug | There was no treatment allocation. Patients administered Brolucizumab by prescription that started before inclusion of the patient into the study were enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Difference in confidence in DAA between reviews with and without enrichment |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hamilton | Ontario | L8G 5E4 | Canada | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42082322 | Derived | 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. |
| Label | URL |
|---|---|
| Results for CRTH258A2402 that is getting linked from the Novartis Clinical Trials Website | View source |
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| ranibizumab | Drug | There was no treatment allocation. Patients administered Ranibizumab by prescription that started before inclusion of the patient into the study were enrolled. |
|
| aflibercept | Drug | There was no treatment allocation. Patients administered Aflibercept by prescription that started before inclusion of the patient into the study were enrolled. |
|
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 |
| 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. | 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 | Month 12 |
| Central Subfield Thickness (CST) change | Course of Central Subfield Thickness (CST) change was provided | 12 months |
| Best-corrected visual acuity change from baseline | Best-corrected visual acuity change from baseline was provided | 12 months |
| Percentage of patients with ocular and non-ocular adverse events | Percentage of patients with ocular and non-ocular adverse events was provided | 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. | 12 months |
| Toronto |
| Ontario |
| M8X 2X3 |
| Canada |
| Novartis Investigative Site | Montreal | Quebec | H1V 1G5 | Canada |
| Novartis Investigative Site | Ludwigsburg | Baden-Wurttemberg | 71638 | Germany |
| Novartis Investigative Site | Bonn | 53105 | Germany |
| Novartis Investigative Site | Düsseldorf | 40212 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Münster | 48145 | Germany |
| Novartis Investigative Site | Ulm | 89075 | Germany |
| Novartis Investigative Site | Glasnevin | Dublin 9 | D09 YN97 | Ireland |
| Novartis Investigative Site | Waterford | 48327 | Ireland |
| Novartis Investigative Site | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | Milan | MI | 20157 | Italy |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Bormujos | Sevilla | 41930 | Spain |
| Novartis Investigative Site | León | 24080 | Spain |
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
| D000069579 | Ranibizumab |
| C533178 | aflibercept |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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