March 19, 2020
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Visual acuity, injection frequency decrease over time in real-world AMD study
In a retrospective study, patients with neovascular age-related macular degeneration treated with anti-VEGF injections experienced decreased visual acuity from baseline and decreased number of injections at 4 years’ follow-up, according to a study.
“In this large real-world study looking at 98,821 eyes from 79,885 patients, with up to 4-year follow-up, both [visual acuity] and injection frequency declined over time. The study highlights the treatment burden experienced by the patients with [neovascular] AMD and need for durable treatment options to have better vision acuity outcomes in the real world,” study co-author Arshad M. Khanani, MD, MA, told Healio/OSN.
The retrospective, multicenter, noninterventional real-world evidence study included 98,821 eyes that received intravitreal anti-VEGF therapy for neovascular AMD from 2012 to 2015. Researchers evaluated the change in visual acuity from baseline, treatment frequencies, annual anti-VEGF injections, bilateral treatment frequencies, annual total clinic visits and non-injection clinic visits as the main outcome measures in the study.
Baseline visual acuities in 2012, 2013 and 2014 were similar, with 53.6 ETDRS letters, 53.2 ETDRS letters and 53.1 ETDRS letters, respectively. However, the baseline visual acuity in 2015 was lower, with an average of 50.7 ETDRS letters. The overall visual acuity for the entire population from 2012 to 2015 was 52.6 ETDRS letters.
The mean number of injections decreased from 7.5 at year 1 to 6.4 injections at year 4. By year 4, 36.7% of eyes had an 8-week or less dosing interval and 21.2% had a 12-week or greater dosing interval. Eyes treated every 8 weeks increased 40% from year 1 to year 4. – by Robert Linnehan
Disclosure: Khanani reports he is a consultant for Adverum, Aerpio, Alcon, Alimera, Allegro, Allergan, Genentech, Novartis, Opthea, PolyPhotonix, Recens Medical, Regenxbio and Oxurion; receives financial support from Aerpio, Adverum, Alcon, Allergan, Clearside Biomedical, DigiSight, Genentech, Kodiak, Novartis, Ophthotech, Opthea and Oxurion; and is a lecturer with Allergan, Genentech and Novartis.
Perspective
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Carl D. Regillo, MD
This is a large, retrospective real-world study that characterizes treatment patterns and outcomes of patients being managed with anti-VEGF therapy for neovascular age-related macular degeneration in the United States over a relatively recent 5-year time frame. There is new information from this analysis, some of which is surprising and some of which is not surprising. Detecting neovascular AMD early, when the visual acuity is good, has been shown to result in the best long-term absolute visual acuity outcomes. Unfortunately, in this study it is surprising that there were no trends found in detecting neovascular AMD at better visual acuity levels over the time frame of 2012 to 2015. It underscores the large unmet need of finding better ways to pick up neovascular AMD earlier before visual acuity declines significantly. When it comes to maintaining vision gains on anti-VEGF therapy, this study, not surprisingly (and unfortunately), shows a steady loss of visual acuity over an average of 4 years of treatment, similar to virtually all real-world studies published to date. Usually, the explanation for this is some combination of potential relative undertreatment and some degree of geographic atrophy development, although the latter is more likely to be a factor beyond the first 2 years of therapy. Interestingly, this downward trend in visual acuity was detected in this study despite a higher annual mean number of anti-VEGF injections (of about six or so per year from years 2 to 4) compared with many other previously published real world studies (of about three to four per year). This points to the relative limited durability of the anti-VEGF agents that have been used in practice since 2006. The hope is that future anti-VEGF agents that hold the promise of having greater durability could help to minimize the relative undertreatment issue in practice and mitigate some of the visual loss that occurs in patients being managed with neovascular AMD.
Carl D. Regillo, MD
OSN Retina/Vitreous Board Member
Disclosures: Regillo reports he receives research grant support from Allergan, Chengdu Kanghong, Genentech, Kodiak, Novartis and Regeneron and consults with Allergan, Chengdu Kanghong, Genentech, Graybug, Kodiak, Notal and Novartis.
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Disclosures:
Khanani reports he is a consultant for Adverum, Aerpio, Alcon, Alimera, Allegro, Allergan, Genentech, Novartis, Opthea, PolyPhotonix, Recens Medical, Regenxbio and Oxurion; receives financial support from Aerpio, Adverum, Alcon, Allergan, Clearside Biomedical, DigiSight, Genentech, Kodiak, Novartis, Ophthotech, Opthea and Oxurion; and is a lecturer with Allergan, Genentech and Novartis.