Neovascular age-related macular degeneration (nAMD) is a leading cause of blindness in Americans over age 60.1 Standard first-line treatment of nAMD includes regular injections of anti-VEGF agents to reduce macular leakage and preserve central vision. But the burden of these treatments is considerable, requiring patients to see an ophthalmologist as often as monthly. Some patients may have to travel long distances to see a specialist and many need to be accompanied by a working-age caregiver or family member.
Tracking long-term outcomes of anti-VEGF therapy in clinical trials is challenging. Genentech, a member of the Roche group, collaborated with Verana Health to leverage data from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) in a research project to learn more about real-world treatment patterns and visual outcomes in patients with nAMD over time.
This research (Starting at 1:31:08), presented at the 2021 American Society of Retina Specialists (ASRS) annual meeting, showed that 18,701 of the 147,888 nAMD patients evaluated had at least 5 years of consecutive data available in the IRIS Registry.2 Mean treatment frequency declined from 7.2injections in the first year to 4.2 in year 6. More than one-quarter of eyes (51,756 or 32%) were switched from one drug to a different one during the study period, with the majority (65%) of those switches occurring from bevacizumab to an on-label agent. The eyes with the most years of follow-up data had better vision at all time points.
This study is the longest time frame we have followed nAMD patients using real-world IRIS Registry data. It represents an important collaboration with industry and an important contribution to the knowledge base about long-term treatment of nAMD.
Leveraging Clinicians to Define the Study Cohort
Verana Health’s role in this research was critical, because the company brings together clinicians with the expertise to frame questions in a way that is clinically relevant and data scientists who can help determine what can or cannot be answered from the data set, alone. Both types of expertise are needed to accurately define the study cohort to ensure that we are measuring what we intend to measure.
For example, data scientists might suggest limiting the study population to only those patients with a visual acuity (VA) measurement on the index (first injection) date because we specifically wanted to know what happened to vision over time. But as a retina specialist, I know that VA is sometimes not measured at that first injection because it was measured at the time of consultation and diagnosis. Working together, we ultimately defined the population as those having a VA measurement on the index date or up to 180 days before. Similarly, in structuring the data queries, we had to think carefully about how to distinguish between a one-time medication substitution vs. an intentional switch from one medication to another to achieve better efficacy.
It is discouraging that a large percentage of patients stopped receiving injections within the 6-year period. Further elucidating real-world treatment patterns can help us to better understand why that happens, what factors affect longer-term preservation of vision, and how to encourage continued patient engagement with treatment.
- Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.
- Leng T, Fevrier HB, LaPrise A, Wykoff CC. 6-year treatment experience of neovascular age-related macular degeneration patients initiating intravitreal anti-VEGF treatment—an IRIS® Registry analysis. 2021 American Society of Retina Specialists annual meeting.