Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neovascular Age-Related Macular Degeneration
Eligibility:
All Genders
18-199 years
Brief 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...
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, ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 28 2023
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT04662944
Start Date
February 23 2021
End Date
June 28 2023
Last Update
June 18 2024
Active Locations (17)
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1
Novartis Investigative Site
Hamilton, Ontario, Canada, L8G 5E4
2
Novartis Investigative Site
Toronto, Ontario, Canada, M8X 2X3
3
Novartis Investigative Site
Montreal, Quebec, Canada, H1V 1G5
4
Novartis Investigative Site
Ludwigsburg, Baden-Wurttemberg, Germany, 71638