Visual Function Benefit After Treatment With Pegcetacoplan: Microperimetry Analysis From The Phase 3 Oaks Trial: Microperimetry: Visual Function Benefit With Pegcetacoplan.
Usha Chakravarthy, Roy Schwartz, Robyn H Guymer, Frank G Holz, Aleksandra V Rachitskaya, Stela Vujosevic, Philip Lewis, Hanne Vorwerk, A Yasin Alibhai, Eric M Moult, Marco U Morales, Caleb Bliss, Caroline R Baumal, Nadia K Waheed
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引用次数: 0
Abstract
Purpose: To evaluate the impact of pegcetacoplan on its ability to slow the loss of visual function using microperimetry endpoints in eyes with geographic atrophy secondary to age-related macular degeneration (AMD).
Design: Post hoc analysis of phase 3 randomized controlled trial data.
Methods: Utilizing data from the OAKS study, which evaluated pegcetacoplan monthly (PM) or every other month (PEOM) versus sham for the treatment of GA secondary to AMD, microperimetry endpoints were assessed at baseline and every 6 months until 24 months, using a 10-2 grid composed of 68 points with a 4-2 threshold strategy. Main outcome measures included the time to development of absolute scotomas in the 4 and 16 central macular points. The number of absolute scotomatous points and mean retinal sensitivity (dB) within the junctional zone extending to 250 µm on either side of autofluorescence-determined GA border was analyzed for change from baseline.
Results: Among 605 patients with subfoveal or nonsubfoveal GA, treatment with pegcetacoplan delayed time to development of absolute scotomas of all 4 central macular points compared to sham at 24 months (PM: hazard ratio [HR]: 0.66 [34% risk reduction]; 95% confidence interval [CI]: 0.46, 0.96; p = 0.0282; PEOM: HR: 0.64 [36% risk reduction]; 95% CI: 0.44, 0.92; p = 0.0164). Similarly, PM and PEOM treatment delayed time to development of absolute scotomas of all 16 central points (PM: HR: 0.57 [43% risk reduction]; 95% CI: 0.33, 0.96; p = 0.0361; PEOM: HR: 0.52 [48% risk reduction]; 95% CI: 0.32, 0.85; p = 0.0084). Across the junctional zone of GA, pegcetacoplan-treated eyes developed fewer absolute scotomatous points (PM difference vs sham pooled: -0.68 points, p = 0.1444; PEOM difference vs sham pooled: -1.14 points, p = 0.0140) and experienced decreased loss of mean retinal sensitivity (PM difference vs sham pooled: 0.56 dB, p = 0.0650; PEOM difference vs sham pooled: 0.71 dB, p = 0.0202) compared with sham at 24 months.
Conclusions: Microperimetry demonstrates a reduced rate of visual function loss in the central macula and junctional zone with pegcetacoplan treatment in GA due to AMD.
期刊介绍：
The American Journal of Ophthalmology is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists describing clinical investigations, clinical observations, and clinically relevant laboratory investigations. Published monthly since 1884, the full text of the American Journal of Ophthalmology and supplementary material are also presented online at www.AJO.com and on ScienceDirect.
The American Journal of Ophthalmology publishes Full-Length Articles, Perspectives, Editorials, Correspondences, Books Reports and Announcements. Brief Reports and Case Reports are no longer published. We recommend submitting Brief Reports and Case Reports to our companion publication, the American Journal of Ophthalmology Case Reports.
Manuscripts are accepted with the understanding that they have not been and will not be published elsewhere substantially in any format, and that there are no ethical problems with the content or data collection. Authors may be requested to produce the data upon which the manuscript is based and to answer expeditiously any questions about the manuscript or its authors.
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