July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Natural history of geographic atrophy secondary to age-related macular degeneration: Proxima A data from the 1-year analysis of 100 patients
Author Affiliations & Notes
  • Giovanni Staurenghi
    Dept of Clinical Sci (Luigi Sacco), University of Milan, Milano, Italy
  • Nancy Holekamp
    Pepose Vision Institute, Chesterfield, Missouri, United States
  • Jordi Mones
    Institut de la Màcula, Barcelona, Spain
  • Fan Tang
    Genentech, Inc., South San Francisco, California, United States
  • Barbara Tong
    Genentech, Inc., South San Francisco, California, United States
  • Ronald A Cantrell
    Genentech, Inc., South San Francisco, California, United States
  • Christopher Brittain
    Genentech, Inc., South San Francisco, California, United States
  • Jason Ehrlich
    Genentech, Inc., South San Francisco, California, United States
  • Hugh Lin
    Genentech, Inc., South San Francisco, California, United States
  • Charles Clifton Wykoff
    Retina Consultants of Houston, Houston, Texas, United States
  • Footnotes
    Commercial Relationships   Giovanni Staurenghi, Alcon Laboratories, Inc. (C), Alcon Laboratories, Inc. (R), Allergan (C), Bayer (C), Bayer (R), Boehringer Ingelheim (C), CenterVue (F), CenterVue (C), CenterVue (R), Heidelberg Engineering (C), Nidek, Inc. (F), Novartis (F), Novartis (C), Novartis (R), Ocular Instruments (P), Optos plc (F), Optos plc (C), Optovue (F), Quantel Medical (F), Quantel Medical (C), Quantel Medical (R), Roche (R), Roche/Genentech, Inc. (C), Zeiss (F), Zeiss (C); Nancy Holekamp, Alimera Sciences, Inc. (F), Alimera Sciences, Inc. (C), Allergan (F), Allergan (C), Genentech, Inc. (F), Genentech, Inc. (C), Katalyst (I), Novartis (C), Ohr Pharmaceutical (F), Ophthotech, Corp. (F), Regeneron Pharmaceuticals, Inc. (C); Jordi Mones, Alcon Laboratories, Inc. (F), Alcon Laboratories, Inc. (C), Alcon Laboratories, Inc. (R), Allergan (C), Bayer (F), Bayer (C), Bayer (R), Genentech, Inc. (C), Genentech, Inc. (R), Notal Vision (C), Novartis (C), Novartis (R), Ophthotech, Corp. (F), Ophthotech, Corp. (C), Ophthotech, Corp. (R), Roche (C), Roche (R); Fan Tang, Genentech, Inc. (E); Barbara Tong, Genentech, Inc. (E); Ronald Cantrell, Genentech, Inc. (E); Christopher Brittain, Genentech, Inc. (E); Jason Ehrlich, Genentech, Inc. (E); Hugh Lin, Genentech, Inc. (E); Charles Wykoff, Apellis Pharmaceuticals (F), Genentech, Inc. (F), Genentech, Inc. (C), Ophthotech, Corp. (F)
  • Footnotes
    Support  F. Hoffman La-Roche Ltd., Basel, Switzerland, provided support for the study and participated in the study design; conducting the study; and data collection, management, and interpretation.
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 5545. doi:
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      Giovanni Staurenghi, Nancy Holekamp, Jordi Mones, Fan Tang, Barbara Tong, Ronald A Cantrell, Christopher Brittain, Jason Ehrlich, Hugh Lin, Charles Clifton Wykoff; Natural history of geographic atrophy secondary to age-related macular degeneration: Proxima A data from the 1-year analysis of 100 patients. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5545.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Geographic atrophy (GA) is a progressive, advanced form of age-related macular degeneration (AMD) that leads to irreversible loss of visual function. There is currently no treatment for GA. Proxima A (NCT02479386) is an observational, prospective study aimed at better understanding the natural history of GA. Proxima A data are presented from the analysis of the first 100 patients to reach the 1-year time point.

Methods : Proxima A enrolled 296 patients aged ≥ 50 years at 91 sites globally. Patients with bilateral GA and without choroidal neovascularization (CNV), nor prior treatment for CNV, are being evaluated at 6-month intervals. The key anatomic outcome is GA lesion size evaluated by fundus autofluorescence imaging. Visual function outcomes include best-corrected visual acuity (BCVA), low-luminance visual acuity (LLVA), monocular and binocular maximum reading speed (MRS), and patient-reported outcomes (PROs), including the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) and the Functional Reading Independence (FRI) Index.

Results : This analysis evaluated data from 100 patients who had completed the 12-month assessment as of the cutoff date, including image grading. Mean baseline (BL) age was 77.8 years, mean BL lesion size was 7.96 mm2, and mean BL BCVA was 66.8 ETDRS letters. Over half of patients (54%) had subfoveal lesions at BL. At 1 year, the mean increase in GA lesion size from BL was 2.084 mm2. Significant BL risk factors for GA lesion progression include BL lesion size ≥ 4 disc areas (DA; 1 DA = 2.54 mm2) and non-subfoveal BL lesion location. Visual function deteriorated across all measured outcomes over 1 year, with BCVA, LLVA, monocular and binocular MRS, NEI VFQ-25, and FRI Index scores each demonstrating a decline from BL to 1 year. LLVA showed a greater correlation with GA lesion size than other visual function end points.

Conclusions : This analysis of Proxima A demonstrates the severe functional impact of GA on patients and the high rate of functional deterioration over 1 year. The magnitude of functional decline was consistent across end points, impacting patient quality of life. Further research is needed to understand the natural history of GA, particularly the rate of visual function decline, because GA remains an untreatable disease.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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