Verana Health Study Using Curated Real-World Data to Replicate Phase III Ophthalmology Clinical Trial Published in OSLI Retina
First Study of its Kind Demonstrates the Promise of Quality RWD in Ophthalmic Clinical Development
SAN FRANCISCO, Jan. 18, 2023 /PRNewswire/ -- Verana Health®—a digital health company elevating quality in real-world data—today announced that medical journal Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina has published a manuscript detailing innovative research showing how curated, de-identified real-world data (RWD) from the American Academy of Ophthalmology (Academy) IRIS® Registry (Intelligent Research in Sight) was used 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 U.S. Food and Drug Administration (FDA) in 2011 of aflibercept (Regeneron) for the treatment of neovascular age-related macular degeneration (wet AMD).
Verana Health's study is the first to use RWD to replicate outcomes in an ophthalmology phase III pivotal trial. The manuscript, "Emulating VIEW 1 and VIEW 2 Clinical Trial Outcome Data Using th American Academy of Ophthalmology IRIS Registry," appeared in the January 15 issue of OSLI Retina and has been updated since the study was presented at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
Following the ARVO presentation, Verana Health researchers conducted modeling to determine whether undetected biases had influenced the data. The study team concluded from this process that their outcomes were valid. In addition, the Verana Health team concluded that only 3.5% of patients on intravitreal aflibercept were being treated according to the every 8 week label (after 3 monthly loading doses).
The Verana Health study demonstrates that researchers can replicate Phase III trial outcomes using curated, de-identified RWD that are fit-for-use. This means that quality RWD could potentially be used to support applications to regulatory agencies. Insights from curated RWD could ultimately help to reduce the time it takes to complete important clinical trials by informing the development of more efficient study designs and potentially reducing the number of patients needed for recruitment. This could allow pharmaceutical companies and medical device manufacturers to bring innovative therapies and treatments to market faster while ensuring their safety and efficacy.
The Verana Health study replicated the study design of the VIEW 1/2 studies and evaluated the outcomes using curated, de-identified RWD contained in the Academy's IRIS Registry, which has a technology foundation managed by Verana Health's VeraQ® population health data engine. After applying the inclusion and exclusion criteria from the VIEW 1/2 studies that were assessable in RWD to the IRIS Registry data, Verana Health researchers identified 4,779 patients who could be compared to the 1,632 subjects in the VIEW 1/2 studies. The proportion of eyes losing <15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters across the VIEW 1 and VIEW 2 studies was similar to the curated IRIS Registry RWD cohort, indicating proof-of-concept, although the mean gains in letters varied across the studies.
Established in 2014, the IRIS Registry is one of the largest specialty society clinical data registries in all of medicine. Verana Health is the Academy's exclusive end-to-end data curation and analytics partner for the IRIS Registry. With access to more than nine years of longitudinal patient RWD, the IRIS Registry and Verana Health are well-suited for conducting the type of RWD analysis performed by the Verana Health team.
"We've been working on this project for several years now and are very excited to see the results published," said Theodore Leng, MD, MS, director of research at the Byers Eye Institute at Stanford University School of Medicine and a Verana Health medical advisor. "This was a great pilot experiment to show that this type of analysis was possible. The next step is to determine whether we can replicate results in other trials and develop confidence in real-world data as a foundation from which we can scale."
To request a copy of the recently published study, conducted by Dr. Leng and a team of Verana Health researchers, visit: https://info.veranahealth.com/view1-view2-manuscript.
About Verana Health
Verana Health® is a digital health company elevating quality in real-world data. Verana Health operates an exclusive real-world data network of more than 20,000 healthcare providers (HCPs) and about 90 million de-identified patients, stemming from its strategic data partnerships with the American Academy of Ophthalmology®, American Academy of Neurology, and American Urological Association. Using its clinician-informed and artificial intelligence-enhanced VeraQ® population health data engine, Verana Health transforms structured and unstructured healthcare data into curated, disease-specific data modules, Qdata®. Verana Health's Qdata helps power analytics solutions and software-as-a-service products for real-world evidence generation, clinical trials enablement, HCP quality reporting, and medical registry data management. Verana Health's quality data and insights help drive progress in medicine to enhance the quality of care and quality of life for patients. For more information, visit www.veranahealth.com.
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