Clinical trial NCT04662944: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: nAMD
Neovascular Age-Related Macular Degeneration
anti-VEGF
RAZORBILL
optical coherence tomography
OCT
Artificial Intelligence
Machine learning
Automatic OCT segmentation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-12-10
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Maximum age (years): 199
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Odds ratio of disease activity assessment from Optical Coherence Tomography (OCTs) with and without enrichment
timeFrame: 12 months
measure: Degree of agreement in classification of disease activity using enriched and non-enriched OCT images
timeFrame: 12 months
Secondary outcomes:
measure: Difference in time needed for Disease Activity Assessment (DAA) between reviews with and without enrichment
timeFrame: 12 months
measure: Difference in confidence in DAA between reviews with and without enrichment
timeFrame: 12 months
measure: Acceptance of Discovery by physicians and whether it can optimize the ophthalmic clinical workflow
timeFrame: Month 12
measure: Percentage of patients with absence of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment
timeFrame: Month 12
measure: Central Subfield Thickness (CST) change
timeFrame: 12 months
measure: Best-corrected visual acuity change from baseline
timeFrame: 12 months
measure: Percentage of patients with ocular and non-ocular adverse events
timeFrame: 12 months
measure: Subjective assessment of system correctness
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Ludwigsburg
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Gottingen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Glasnevin
country: Ireland
facility: Novartis Investigative Site
state: Dublin 9
city: Waterford
country: Ireland
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Bormujos
country: Spain
facility: Novartis Investigative Site
state: Sevilla
city: Leon
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: