Discovery for Clinical Studies

Discovery for Clinical Studies is a web-based platform developed by RetinAI (Ikerian AG) for managing data collection and analysis in ophthalmology clinical trials. It is designed for pharmaceutical and life sciences companies, reading centres, and clinical sites involved in multi-centre studies, providing a single environment where authorised stakeholders can access, review, and act on trial data in real time.

The platform addresses common inefficiencies in traditional clinical study workflows, where sequential data transfer between sites and reading centres adds time to recruitment, reading, reviewing, and data transfer stages. Discovery enables parallel workflows and centralises data analysis to reduce delays and support faster decision-making throughout a study.

Core Platform Capabilities

• Single platform for all trial data, accessible securely by authorised users globally
• Real-time data collection and insight generation to support monitoring throughout study development
• Simultaneous AI processing of imaging and clinical data
• Ability to deploy automatic reading tools on the platform, with potential to reduce reading centre costs
• Full control of data for additional analysis beyond primary study objectives
• No requirement for vendor-specific software, reducing costs
• Supports flexibility in the geographic location of sites and stakeholders
• Ensures data transparency and consistency across sites
• Electronic Case Report Forms (eCRFs) for collecting clinical patient data and multi-modality imaging data

Clinical Challenges Addressed

• Delays and loss to follow-up: Patient enrolment involving third-party evaluation increases onboarding time and risks loss to follow-up between first visit and enrolment. GO/NO GO decisions can be delayed when aggregating data from multiple sites.
• Financial and operational risk: Clinical studies represent a major expense for pharma and life sciences companies, with failure risk linked to suboptimal study design or inadequate patient subgroup definition.

Solutions Provided

• Centralised data collection to increase visibility and monitoring throughout study development and enable real-time decisions
• Real-time evaluation of enrolment criteria and endpoints to support patient enrolment with live data analysis
• Same-day patient evaluation workflows
• Study progress monitoring accessible anywhere at any time

Active and Completed Studies

• Razorbill Study (Sponsor: Novartis): Observational, non-interventional, open-label study in neovascular age-related macular degeneration (nAMD), involving up to 20 centres across 5 countries and 424 patients. Discovery was used for data collection in Phase I and for automatic OCT enrichment using RetinAI's fluid and layer segmentation certified models in Phase II. The study evaluates the influence of AI-based automated OCT image enrichment on disease activity assessment in nAMD patients treated with anti-VEGF injections.
• Better Study (Sponsor: Isarna Therapeutics GmbH): Phase IIa, multicentre study evaluating ISTH0036 in diabetic macular oedema (DME) and nAMD, with up to 50 patients planned. Discovery provided a same-day data evaluation workflow for enrolment by enabling review of clinical and imaging data between sites and the reading centre. RetinAI's fluid and layer segmentation models were used to evaluate primary endpoints including reduction of fluid and central macula thickness.
• CARDS Study: Validation study of the LuxIA algorithm for automated Diabetic Retinopathy screening, conducted across multiple centres in Spain with 960 subjects planned. Discovery was used for data collection via eCRFs capturing clinical patient data and multi-modality imaging including fundus images and OCTs. During the review phase, the platform's workflow ensured graders were blinded to each other's outcomes to support unbiased analysis.

Regulatory and Compliance Information

• RetinAI Discovery® is a CE-marked medical device under EU Medical Devices Regulation (EU) 2017/745 (CE2797)
• RetinAI Discovery® is cleared for clinical use by the FDA
• LuxIA® (Diabetic Retinopathy Screening model) is CE-marked
• AI modules for biomarkers, fluid, and layer segmentation and quantification in retinal pathologies are designated Research Use Only (RUO) in the USA
• The platform is not intended to replace professional medical advice, diagnosis, or treatment

RetinAI is headquartered in Bern, Switzerland, with a US office in Boston, MA. The company operates under the legal entity Ikerian AG and holds relevant certifications for its medical device products.