Verana Health Leads First-of-its-Kind Study Demonstrating Promise of Real-World Data in Ophthalmic Clinical Development
Verana Health, a healthcare technology and analytics innovator transforming multi-specialty clinical data into real-world evidence, today unveiled ground-breaking research during the 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. In a first-of-its kind study, Verana Health demonstrated that it was able to successfully use real world data (RWD) to replicate primary outcome measures of two large-scale randomized controlled trials (RCTs) in ophthalmology—the VIEW 1 and VIEW 2 (VIEW 1/2) pivotal trials. VIEW 1/2 led to the clearance by the Food & Drug Administration (FDA) of aflibercept (EYLEA→, Regeneron) for the treatment of neovascular age-related macular degeneration (wet AMD) in 2011.
In this electronic health record (EHR) based registry study, investigators replicated the study design and evaluated the outcomes using RWD contained in the American Academy of Ophthalmology IRIS→ Registry (Intelligent Research in Sight), the world’s largest single-specialty clinical database. The same inclusion and exclusion criteria of the VIEW 1/2 studies were successfully applied to the IRIS Registry and resulted in the identification of 4779 patients that could be compared to the 1632 subjects in the VIEW 1/2 studies. The proportion of eyes losing <15 ETDRS letters across the VIEW 1 and VIEW 2 studies was similar to the IRIS Registry real-world data cohort, indicating proof-of-concept, although the mean gains in letters varied across the studies.
“Before now, we did not know whether phase 3 clinical trial data and outcomes were represented in the real-world data contained in the IRIS Registry,” said Theodore Leng, MD, Medical Advisor to Verana Health and Director of Clinical and Translational Research at the Byers Eye Institute at Stanford, Stanford University Medical School. “We’re excited to discover that in this retrospective study, primary outcome measures were reproducible in the IRIS Registry, thus making it the very first time that a large-scale, phase 3 randomized controlled trial in ophthalmology was able to be replicated using a real-world data set. This has exciting implications for clinicians, investigators, and drug and device development companies, including the potential to validate trial endpoints as a measure of treatment effectiveness.”
In a second presentation that explored whether linking imaging metadata from various platforms to IRIS Registry clinical encounters is possible, Verana Health was able to harmonize more than 2 million images to 49,000 patients in the IRIS Registry. Ophthalmic diagnostic imaging is indispensable to clinical practice. Historically, however, metadata harmonization between different device manufacturers and modalities has been challenging. This research serves as a proof-of-concept model demonstrating that linking images to IRIS Registry encounters through metadata is possible at scale.
“The research presented at ARVO by Verana Health is meaningful for the future of real-world evidence in ophthalmology. The groundbreaking replication of the VIEW 1/2 clinical trials outcomes data shows the potential value real-world data can bring in helping to accelerate clinical trials,” said David W. Parke II, MD, CEO of the American Academy of Ophthalmology. “The research demonstrating the viability of linking imaging metadata to IRIS Registry encounters is also encouraging. Currently, the IRIS Registry does not contain images, yet they are a critical component of the daily practice of ophthalmology. Enriching the IRIS Registry with images would increase our ability to answer important research questions and improve patient care, so I am excited to see how this work comes to life.”
For more information, see the list of scientific presentations below.
- Leng, T, et al. “AAO IRIS Registry Data Replicates VIEW 1 and VIEW 2 Clinical Trial Outcome Data.”
- Mbagwu, M, et al. “Large Scale Cross-Vendor Linkage of Ophthalmic Imaging and American Academy of Ophthalmology IRIS® Registry Clinical Data.”
- Kras, A, et al. “Extending Interoperability in Ophthalmology Through Fast Healthcare Interoperability Resource (FHIR).”
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