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 (RAZORBILL)

Novartis

Status

Completed

Conditions

Neovascular Age-Related Macular Degeneration

Treatments

Drug: brolucizumab

Drug: ranibizumab

Drug: aflibercept

Study type

Observational

Funder types

Industry

Identifiers

NCT04662944

CRTH258A2402

Details and patient eligibility

About

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

Full 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.

Enrollment

494 patients

Sex

All

Ages

18 to 199 years old

Volunteers

No Healthy Volunteers

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