In May 2021, I wrote about Verana Health’s innovative research that demonstrated how curated real-world data (RWD) can be used to help emulate primary outcomes measures. Specifically, the Verana Health team and I set out to determine whether the American Academy of Ophthalmology (Academy) IRIS® Registry (Intelligent Research in Sight) data, curated from electronic health records (EHRs), could help produce results similar to a pair of foundational studies that led to the Food and Drug Administration’s approval in 2011 of aflibercept to treat wet AMD, or neovascular age-related macular degeneration (nAMD).
Verana Health’s study, the first to use RWD to emulate outcomes in an ophthalmic phase III pivotal trial, was presented at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
This month, the research was published in OSLI Retina, the official journal of Retina World Congress, and includes updates since our 2021 ARVO presentation.
Emulating the VIEW Studies with RWD
Nearly one million patients in the U.S. have wet AMD, which can lead to severely diminished vision or even blindness if left untreated. The VIEW (VEGF Trap: Investigation of Efficacy and Safety in Wet AMD) studies, conducted by Regeneron Pharmaceuticals and Bayer Healthcare,
consisted of two randomized, double-masked, Phase III clinical trials evaluating aflibercept injections in the treatment of wet AMD over a two-year period.
The VIEW 1 study included more than 1,200 patients in the U.S. and Canada, while VIEW 2 followed a similar number of patients in Europe, Asia Pacific, Japan, and Latin America. More than 94% of patients maintained vision after one year, losing less than three lines of vision a year after their baseline visual acuity (VA) measurement.
Verana Health’s research team assessed whether analyzing IRIS Registry data could emulate the VIEW RCT eligibility criteria, treatment protocol regimen, and primary endpoint after accounting for missing endpoint data and population differences. In addition, our team evaluated baseline differences between IRIS Registry treatment groups and mean change in VA at one year from starting treatment.
The Verana Health study helped emulate the study design of the VIEW 1/2 studies and evaluated the outcomes using RWD contained in the IRIS Registry. Applying the same inclusion and exclusion criteria to IRIS Registry data as the VIEW 1/2 studies, we identified 4,779 patients who could be compared to the 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 IRIS Registry real-world data cohort, indicating proof-of-concept.
Updates Since Our Presentation at ARVO
Since presenting results at the 2021 ARVO meeting, Verana Health researchers conducted modeling to determine whether undetected biases had influenced the data. We are happy to report that this modeling confirmed that our outcomes were valid. In addition, the Verana Health team concluded that only 3.5% of patients were being treated with intravitreal aflibercept every 8 weeks after 3 monthly loading doses (according to the drug’s label).
Our study is significant because it shows that researchers can help emulate Phase III trial outcomes using curated, de-identified RWD. This means that quality RWD could potentially be used to support applications to regulatory agencies.
About the IRIS Registry
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, including more than 454 million patient encounters from nearly 79 million unique patients in the IRIS Registry database, Verana Health is well-suited for conducting this type of RWD analysis. The next step is to see whether we can help emulate results in other trials and build confidence in RWD in clinical and post-marketing studies.
High-quality, curated, de-identified RWD, such as what can be extracted from the IRIS Registry, ultimately may reduce the time it takes to complete important clinical trials, which will help life sciences companies and device makers to get their products onto the market faster while ensuring their safety and efficacy. Ultimately, this will improve the treatment options available to help preserve sight and improve vision outcomes for patients.
To request a copy of this manuscript from Verana Health, visit: https://info.veranahealth.com/view1-view2-manuscript