Verana Health and Bitfount collaborate on AI-based ophthalmology trial prescreening

Verana Health and Bitfount have announced a partnership to integrate ophthalmic imaging and electronic health record data to support patient identification and prescreening for ophthalmology clinical trials.

The Baseline

• Verana Health and Bitfount to will combine AI-based ophthalmic image analysis with electronic health record data for clinical trial prescreening.
• The approach uses federated AI and real-world data to identify patients who may meet study-specific eligibility criteria while keeping imaging analysis at clinical sites.
• A previous validation study demonstrated the potential of AI-assisted prescreening, although the integrated system's impact on recruitment efficiency has not yet been reported.

Verana Health has announced a collaboration with Bitfount to combine AI-based ophthalmic image analysis with real-world data (RWD) to identify patients who may meet study-specific eligibility criteria. The approach is intended to reduce manual screening and improve recruitment efficiency in ophthalmology trials.

Identifying eligible patients can require reviewing multiple sources of clinical information, including medical records and diagnostic images. Optical coherence tomography (OCT) and fundus photography are commonly used to diagnose and monitor conditions such as diabetic retinopathy, glaucoma, and macular degeneration, but assessing these images alongside clinical records can involve substantial manual review.

The collaboration combines Verana Health’s RWD capabilities with Bitfount’s federated AI technology. Verana Health has exclusive access to more than 12 years of longitudinal ophthalmology data covering over 90 million de-identified patients through the American Academy of Ophthalmology’s IRIS Registry (Intelligent Research in Sight). Bitfount’s algorithms analyze existing OCT and fundus images locally at participating clinical sites to assess imaging-related eligibility. The resulting indicators are combined with electronic health record (EHR) data, including information extracted from unstructured clinical notes using AI, to evaluate patients against study-specific inclusion and exclusion criteria.

The results are made available through Verana Trial Connect (VTC), Verana Health’s HIPAA-compliant clinical trial platform, and Bitfount’s on-premise application. VTC presents imaging eligibility indicators alongside EHR-based criteria, allowing research teams to review patients identified during prescreening. According to the companies, the approach could reduce manual chart review, limit screening failures, and shorten recruitment timelines while keeping imaging analysis within participating clinical sites.

Commenting on the collaboration, Sujay Jadhav, CEO, Verana Health, highlighted the potential role of RWD in improving trial design and recruitment:

"Clinical trials informed by RWD start with a stronger foundation, and are more likely to avoid the mismatched enrollment, study amendments and costly delays that plague traditional trials.”

The collaboration builds on a previously published clinical validation study examining AI-assisted recruitment for geographic atrophy, an advanced form of age-related macular degeneration. Using retrospective data from 306,651 patients at Moorfields Eye Hospital, researchers compared AI-based analysis of OCT scans with conventional EHR searches. The AI approach shortlisted 1139 potentially eligible patients, with a positive predictive value of 63%, compared with 693 patients and 40% for EHR searches alone. Combining both methods increased the positive predictive value to 86%, identifying 604 potentially eligible patients.

While the earlier study demonstrated the potential of AI-assisted prescreening, the companies have not reported quantitative results showing whether the newly integrated system reduces recruitment timelines or screening failure rates in participating trials.

Blaise Thomson, CEO and Co-Founder, Bitfount, commented on the integration of clinical and imaging data:

“By combining exclusive real-world ophthalmology data with leading OCT and fundus image analysis, we're equipping research teams with the tools needed to design and run studies that reflect the actual nature of patient populations, ensuring that future treatments are informed by and beneficial for all.”