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

Neovascular Age-Related Macular Degeneration Clinical Trial

— RAZORBILL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662944
• Other study ID #: CRTH258A2402
• Status: Completed
• Start date: February 23, 2021
• Est. completion date: June 28, 2023

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 199 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• brolucizumab
There was no treatment allocation. Patients administered Brolucizumab by prescription that started before inclusion of the patient into the study were enrolled.
• ranibizumab
There was no treatment allocation. Patients administered Ranibizumab by prescription that started before inclusion of the patient into the study were enrolled.
• aflibercept
There was no treatment allocation. Patients administered Aflibercept by prescription that started before inclusion of the patient into the study were enrolled.

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Gottingen
Germany	Novartis Investigative Site	Ludwigsburg	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Ulm
Ireland	Novartis Investigative Site	Glasnevin	Dublin 9
Ireland	Novartis Investigative Site	Waterford
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Bormujos	Sevilla
Spain	Novartis Investigative Site	Leon

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Germany,  Ireland,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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	12 months
Secondary	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
Secondary	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
Secondary	Central Subfield Thickness (CST) change	Course of Central Subfield Thickness (CST) change was provided	12 months
Secondary	Best-corrected visual acuity change from baseline	Best-corrected visual acuity change from baseline was provided	12 months
Secondary	Percentage of patients with ocular and non-ocular adverse events	Percentage of patients with ocular and non-ocular adverse events was provided	12 months
Secondary	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

External Links

•   Results for CRTH258A2402 that is getting linked from the Novartis Clinical Trials Website