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%2 of OCT readings compared to Reading Centers.
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.
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:
The study consists of two parts:
Anonymised patients’ files are uploaded to Discovery.
Additional data is collected through 5 eCRF templates
RetinAI Discovery is a CE-marked medical device according to the Medical Devices Regulation (EU) 2017/745
and the AI models are CE-marked devices according to Medical Devices Directive 93/42/EEC
RetinAI Discovery® is a 510(k) FDA Cleared medical device in US.
RetinAI Discovery® and Retinai® are both trademarks of RetinAI Medical AG.
Discovery and AI Models are CE-Marked medical devices since April 2020 & December 2020 respectively.