Ophthalmology Qdata Module to Provide Real-World Evidence from GA Patients in American Academy of Ophthalmology’s IRIS® Registry
SAN FRANCISCO, April 19, 2023 /PRNewswire/ — Verana Health®—a digital health company elevating quality in real-world data (RWD)— will announce the development of Qdata® Geographic Atrophy at ARVO 2023, the annual conference of the Association for Research in Vision and Ophthalmology, which takes place in New Orleans between April 23 to 27. This new offering already provides a comprehensive clinical view of real-world data from almost 350,000 de-identified geographic atrophy (GA) patients, making Verana Health the leading company able to identify GA diagnosis from both electronic health records (EHR) and images for research. As Verana Health ingests even more ophthalmic images in 2023, this number will continue to grow.
Verana Health has developed novel machine learning (ML) and computer vision (CV) algorithms to identify and filter clinical images into high-quality, research-ready image data that provide quality insights. Combining this image data with EHR data from the American Academy of Ophthalmology (Academy) IRIS® Registry (Intelligent Research in Sight) will support researchers in gaining a comprehensive view into the GA patient journey. Verana Health is the Academy’s exclusive end-to-end data curation and analytics partner for the IRIS Registry.
A condition in which large sections of the retina cease to function, GA impacts an estimated 1 million Americans and can cause irreversible vision loss and even blindness. This disease accounts for approximately 20% of legal blindness in the U.S. Approximately 1% of Americans have the atrophic form in at least one eye, but this increases to 3.5% in patients older than 75 and to nearly 25% of people over age 90.
Qdata Geographic Atrophy includes de-identified data from more than 8,000 providers and 2,600 GA patients who have linked images and is rapidly growing. The module will help researchers evaluate GA disease severity and track disease progression over time using Verana Health’s curation of key variables from ophthalmic images and unstructured notes. These variables include:
- Visual acuity (derived from clinician notes) – Visual acuity (VA) is an outcome measure not available in claims that can help measure functional burden of the disease.
- Subfoveal involvement (confirmed via images) – Subfoveal involvement represents an important clinical finding and is an important hallmark of late-stage GA.
- Lesion size and characteristics (derived from images) – GA progression is commonly assessed as the enlargement of GA lesions. This variable follows the clinical trial definition of measuring lesion size through tracing the boundaries of GA lesions present on an image to help calculate annual GA growth rate.
The new module will help life sciences companies in the following ways:
- Clinical Development – Enhance the ability to identify potential study sites with specific GA profiles or support trial design and optimization.
- HEOR and Medical Affairs – Evaluate and track the patient journey for de-identified patients with GA, including the natural history of the condition, treatment patterns and outcomes, and postmarketing effectiveness.
- Commercialization – Identify basic clinical characteristics and demographics of the de-identified patients who are treated for GA to generate market insights and support sales forecasting.
“When it comes to geographic atrophy, a picture truly is worth a thousand words in capturing the size and progression of a lesion and understanding whether there might be concurrent comorbidities such as choroidal neovascularization that could further impact vision,” said Durga Borkar, MD, MMCi, a vitreoretinal surgeon at Duke University Eye Center and a medical advisor to Verana Health. “These are real-world images that are being taken in physicians’ offices outside of a research setting. When you create machine learning algorithms using these images, they’re more broadly applicable than what you might develop using clinical trial images alone.”
The IRIS Registry is one of the largest specialty society clinical data registries in medicine, containing ophthalmic records from more than 78 million patients over approximately 10 years. Verana Health is responsible for IRIS Registry data curation, EHR integration, analytics, practice support, and quality reporting for physicians contributing to the registry.
“Ophthalmic images historically have been underutilized as a source of real-world data,” said Sujay Jadhav, CEO of Verana Health. “The addition of images to the IRIS Registry EHR data will enable new data-driven insights to support innovations in ophthalmology to ultimately help improve eye care and quality of life for patients with GA and other ophthalmological conditions.”
Research to be presented at ARVO 23
In addition to announcing Qdata Geographic Atrophy with Images at ARVO 2023, Verana Health will present four abstracts:
1. Geographic Atrophy Diagnosis in the IRISⓇ Registry: A Comparison Between Images and ICD-10 Codes
- Zhongdi Chu, Ph.D., will present research led by Verana Health to assess the accuracy of clinically documented GA diagnosis and subfoveal involvement status using real-world imaging and EHR data in the IRIS Registry. The poster presentation will be on Saturday, April 22, from 3 to 3:30 p.m. during Session 3 in the Poster Hall.
2. Automated Identification of Geographic Atrophy Eyes With and Without Subfoveal Involvement Using Machine Learning and Real-world Ophthalmic Images in the IRISⓇ Registry
- Zhongdi Chu, Ph.D. will present research led by Verana Health to develop an ML-aided pipeline to identify eyes with GA that have subfoveal involvement and eyes without subfoveal involvement using real-world optical coherence tomography (OCT) images linked to the IRIS Registry. The poster presentation will be on Sunday, April 23, from 8 to 9:45 a.m. during Session 111 in the Poster Hall.
3. Early Treatment Patterns and Outcomes in Patients with Neovascular Age-Related Macular Degeneration Initiating Faricimab: An IRISⓇ Registry Analysis (FARETINA-AMD study)
- The FARETINA study describes the largest real-world evaluation of injection frequency and clinical response of neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME) patients initiating faricimab. Anti-Vascular Endothelial Growth Factor (VEGF) intravitreal agents are the standard of care for both AMD and DME and require frequent injections. Faricimab has a novel mechanism of action and is the only bispecific antibody for intraocular use that independently binds and neutralizes both angiopoietin-2 and VEGF-A. Limited real-world data exists on treatment patterns and outcomes of faricimab.
- Durga Borkar, M.D., MMCi, will present the FARETINA-AMD research led by Genentech. The study describes the largest real-world evaluation of injection frequency and clinical response of AMD patients initiating faricimab. The poster presentation will be on Monday, April 24, from 3:15 to 5:00 p.m.
4. Early Treatment Patterns and Outcomes in Patients with Diabetic Macular Edema Treated with Faricimab: An IRISⓇ Registry Analysis (FARETINA-DME study)
- This poster presentation is also based on the FARETINA study described above, with a focus on DME patients.
- David Tabano, Ph.D. will present the FARETINA-DME research led by Genentech. The study describes the largest real-world evaluation of injection frequency and clinical response of DME patients initiating faricimab. The poster presentation will be on Tuesday, April 25, from 8:45 to 10:30 a.m.
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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