Impact of Baseline Characteristics on Geographic Atrophy Progression in the FILLY Trial Evaluating the Complement C3 Inhibitor Pegcetacoplan.

Steinle, Nathan C, Pearce, Ian, Monés, Jordi ORCID: 0000-0003-3685-2160, Metlapally, Ravi, Saroj, Namrata, Hamdani, Mohamed, Ribeiro, Ramiro, Rosenfeld, Philip J and Lad, Eleonora M (2021) Impact of Baseline Characteristics on Geographic Atrophy Progression in the FILLY Trial Evaluating the Complement C3 Inhibitor Pegcetacoplan. American journal of ophthalmology, 227. pp. 116-124.

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Official URL: http://dx.doi.org/10.1016/j.ajo.2021.02.031

Abstract

<h4>Purpose</h4>To evaluate the effect of select baseline characteristics on geographic atrophy (GA) progression in eyes receiving intravitreal pegcetacoplan or sham.<h4>Design</h4>Phase 2 multicenter, randomized, single-masked, sham-controlled trial.<h4>Methods</h4>Patients with GA received 15 mg pegcetacoplan monthly or every other month (EOM), or sham injection monthly or EOM for 12 months. Primary efficacy endpoint was change in GA lesion size (square root) from baseline. Post hoc analysis evaluated the effects of age; gender; lesion size, focality, and location (extrafoveal vs foveal); pseudodrusen status; best-corrected visual acuity (BCVA); and low-luminance deficit (LLD) on GA progression at Month 12.<h4>Results</h4>Of 246 randomized patients, 192 with 12-month data were included in this analysis. Overall mean (standard deviation) change in lesion size (mm) was 0.26 (0.17) (P < .01), 0.27 (0.27) (P < .05), and 0.36 (0.21) in the monthly pegcetacoplan (n = 67), EOM pegcetacoplan (n = 58), and sham (n = 67) groups, respectively. In univariate analysis, patients with extrafoveal lesions (P < .001), BCVA ≥20/60 (P = .001), and larger LLD (P = .002) had greater mean changes in lesion size. Multivariate analysis confirmed significant association of extrafoveal lesions (P = .001) and larger LLD (P = .023) with GA progression. Monthly and EOM pegcetacoplan significantly reduced progression (P < .05) when controlling for these risk factors.<h4>Conclusions</h4>Extrafoveal lesions and larger LLD are potential risk factors for GA progression. Pegcetacoplan treatment significantly controlled GA progression even after accounting for these risk factors.

Item Type:	Article
Uncontrolled Keywords:	Humans, Vision Disorders, Disease Progression, Peptides, Cyclic, Treatment Outcome, Prospective Studies, Single-Blind Method, Visual Acuity, Aged, Aged, 80 and over, Middle Aged, Complement C3, Female, Male, Complement Inactivating Agents, Geographic Atrophy, Intravitreal Injections
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User:	Symplectic Admin
Date Deposited:	31 Jan 2023 10:39
Last Modified:	31 Jan 2023 10:39
DOI:	10.1016/j.ajo.2021.02.031
Open Access URL:	https://doi.org/10.1016/j.ajo.2021.02.031
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3168002