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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)

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ClinicalTrials.gov Identifier: NCT04662944
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date November 24, 2020
First Posted Date December 10, 2020
Last Update Posted Date July 20, 2021
Actual Study Start Date February 12, 2021
Estimated Primary Completion Date August 2, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2020)
  • Odds ratio of disease activity identification from Optical Coherence Tomography (OCTs) with and without automatic augmentation [ Time Frame: 12 months ]
    An odds ratio of disease activity identification from OCTs with and without automatic segmentation will be reported with a 95% confidence interval.
  • Degree of agreement in classification of disease activity using segmented OCT images [ Time Frame: 12 months ]
    Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using segmented OCT images
  • Degree of agreement in classification of disease activity using non-segmented OCT images [ Time Frame: 12 months ]
    Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using non-segmented OCT images
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 9, 2020)
  • Assess if Discovery is accepted by physicians and whether it can optimize the ophthalmic clinical workflow [ Time Frame: Month 12 ]
    Physicians will use 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 will be invited to complete questionnaires regarding their user experience.
  • Percentage (%) of patients absent of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment [ Time Frame: Month 12 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan
  • Estimate Central Subfield Thickness (CST) change and correlation with Visual Acuity (VA) [ Time Frame: 12 months ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan
  • Visual Acuity (VA) change from baseline [ Time Frame: Baseline, month 12 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan
  • Percentage (%) of patients with ocular and non-ocular adverse events [ Time Frame: 12 months ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Brief Summary RAZORBILL is 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 is 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 comprises a prospective data collection phase and a retrospective analysis of OCT images phase. The prospective observation period per patient will be up to 12 months.

The study will include 720 patients (naïve patients and patients who have 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. Patients will be enrolled at approximately 20 centers across 6 countries.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.
Condition Neovascular Age-Related Macular Degeneration
Intervention
  • Drug: brolucizumab
    There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
  • Drug: ranibizumab
    There is no treatment allocation. Patients administered Ranibizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
  • Drug: aflibercept
    There is no treatment allocation. Patients administered Aflibercept by prescription that have started before inclusion of the patient into the study will be enrolled.
Study Groups/Cohorts Licensed anti-VEGFs
Patients being treated for nAMD with licensed anti-VEGFs
Interventions:
  • Drug: brolucizumab
  • Drug: ranibizumab
  • Drug: aflibercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 9, 2020)
720
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2, 2022
Estimated Primary Completion Date August 2, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of nAMD
  • Male and Female patients with ≥40 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 199 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries Canada,   Germany,   Ireland,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04662944
Other Study ID Numbers CRTH258A2402
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor Novartis Pharmaceuticals
Collaborators Not Provided
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2021