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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; Metlapally, Ravi; Saroj, Namrata; Hamdani, Mohamed; Ribeiro, Ramiro; Rosenfeld, Philip J; Lad, Eleonora M.
Afiliación
  • Steinle NC; From the California Retina Consultants, Santa Barbara, California, USA.
  • Pearce I; St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, England, United Kingdom; Department of Eye and Vision Science, University of Liverpool, England, United Kingdom.
  • Monés J; Barcelona Macula Foundation, Institut de la Màcula, Hospital Quirón Teknon, Barcelona, Spain.
  • Metlapally R; Apellis Pharmaceuticals, Waltham, Massachusetts, USA.
  • Saroj N; All Eyes Consulting, LLC, New York, New York, USA.
  • Hamdani M; Apellis Pharmaceuticals, Waltham, Massachusetts, USA.
  • Ribeiro R; Apellis Pharmaceuticals, Waltham, Massachusetts, USA.
  • Rosenfeld PJ; Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Lad EM; Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina, USA. Electronic address: nora.lad@duke.edu.
Am J Ophthalmol ; 227: 116-124, 2021 07.
Article en En | MEDLINE | ID: mdl-33675755
PURPOSE: To evaluate the effect of select baseline characteristics on geographic atrophy (GA) progression in eyes receiving intravitreal pegcetacoplan or sham. DESIGN: Phase 2 multicenter, randomized, single-masked, sham-controlled trial. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Péptidos Cíclicos / Complemento C3 / Inactivadores del Complemento / Atrofia Geográfica Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Risk_factors_studies Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Am J Ophthalmol Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Péptidos Cíclicos / Complemento C3 / Inactivadores del Complemento / Atrofia Geográfica Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Risk_factors_studies Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Am J Ophthalmol Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos