STUDIES

The Razorbill study

The Challenges:

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The standard of care for nAMD is repeated intravitreal injection with anti-VEGFs injections.
Evidence shows that optimal outcomes are achieved with treatment frequency of approximately 8 injections/ year.
However, evidence also show that the average number of injections and treatment visits observed in real- world clinical situations are significantly lower than expected. Contributing factor to this undertreatment is an overwhelmed healthcare system which cause physicians to miss disease activity in 16.6%¹ to 29.6%²of OCT readings compared to Reading Centers.

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Clinical studies are complex, expensive and time consuming.‍

Today the average time to bring a new drug to the market is ten to twelve years³.
The initial phase of R&D, drug discovery, can take five to six years, followed by an additional five to seven years for clinical trials.
To bring a new drug to the market takes an estimated average cost of $2.6 billion.
Key inefficiencies are:‍

- decentralized data in multiple locations
- long time (e.g. 9-10 months) to submit to regulatory approval, which then can take up.

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Gunnemann Fet al. (2017) Influence of OCT-examination during ranibizumab treatment of AMD patients in a real-life setting (Ocean study). Invest. Ophthalmol. Vis. Sci;58:412.

Martin DF, Maguire MG, et al. (2012). Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology 2012;1388–98.
Deloitte. Intelligent Clinical Trials. (2020). https://www2.deloitte.com/content/dam/insights/us/articles/22934_intelligent-clinical-trials/DI_Intelligent-clinical-trials.pdf

2 challenges, 1 solution - Discovery^®

The Razorbill study hypothesizes that Discovery will add specific supportive information for a faster and more precise evaluation of anatomical signs of disease activity particularly in less specialised centres.

Discovery as a clinical study tool improve efficiency providing:‍

‍real-time transparency & accessibility
decentralized access to data
one-stop solution for: data collection (eCRFs)-image collection-image analysis-faster analysis supported by AI, quantification measurements

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Check out Discovery for Clinical Studies

Learn more about the features of Discovery for Clinical Studies and the benefits it brings to Clinical Studies' processes.

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Study design
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The study consists of two parts:

PHASE 1

Prospective data collection
5 countries
18 clinics / sites

Key activities:‍

Anonymised patients’ files are uploaded to Discovery.
Additional data is collected through 5 eCRF templates

PHASE 2

OCT Enrichment analysis
5 countries
36 reviewers

Key activities:

Patients are redistributed to reviewers automatically based on protocol logic
Each reviewer analyses patients with and without AI enhancement
OCT analysis data is collected through 1 eCRF template

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READ THE PUBLICATION HERE

Partners

Project sponsor

Global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide.

Check the other clinical studies we are involved in:

The BETTER study

The CARDS study

Check our Discovery for Clinical Studies