June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Understanding the natural history of geographic atrophy secondary to age-related macular degeneration: Baseline data from Proxima A
Author Affiliations & Notes
  • Brandon Busbee
    Tennessee Retina, Nashville, Tennessee, United States
  • Jordi Monés
    Institut de la Màcula, Barcelona, Spain
  • Charles Clifton Wykoff
    Retina Consultants of Houston, Houston, Texas, United States
  • Giovanni Staurenghi
    University Eye Clinic, Milan, Italy
  • 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
  • Nancy Holekamp
    Barnes Retina Institute, St. Louis, Missouri, United States
  • Footnotes
    Commercial Relationships   Brandon Busbee, Aerpio (C), Akorn, Inc. (P), Akorn, Inc. (R), Genentech, Inc. (C), Regeneron Pharmaceuticals, Inc. (C), Valeant (C); Jordi Monés, Alcon (F), Alcon (C), Alcon (R), Allergan (C), Bayer (F), Bayer (C), Bayer (R), Genentech, Inc. (C), Genentech, Inc. (R), Notal Vision (I), Notal Vision (C), Novartis (C), Novartis (R), Ophthotech, Corp. (F), Ophthotech, Corp. (I), Ophthotech, Corp. (C), Ophthotech, Corp. (R), Roche (C), Roche (R); Charles Wykoff, Alcon Laboratories, Inc. (F), Alimera Sciences, Inc. (C), Allegro Ophthalmics (F), Allergan (F), Allergan (R), Ampio Pharmaceuticals (F), Apellis Pharmaceuticals (F), Bayer (F), Clearside Biomedical, Inc. (F), DORC International (C), DRCR Network (F), Genentech, Inc. (F), Genentech, Inc. (C), Iconic Therapeutics (F), ONL Therapeutics (I), ONL Therapeutics (C), Regeneron Pharmaceuticals, Inc. (F), Regeneron Pharmaceuticals, Inc. (R), ThromboGenics, Inc. (F), Tyrogenex (F), Valeant (C); Giovanni Staurenghi, Alcon (C), Alcon (R), Allergan (C), Bayer (C), Bayer (R), Boehringer Ingelheim (C), Genentech, Inc. (C), Heidelberg Engineering (C), Heidelberg Engineering (R), Novartis (F), Novartis (C), Novartis (R), Ocular Instruments (P), Optos (C), Optovue (F), Roche (C), Zeiss (F), Zeiss (C); 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); Nancy Holekamp, Alimera Sciences, Inc. (C), Alimera Sciences, Inc. (R), Allergan (C), Allergan (R), Genentech, Inc. (C), Genentech, Inc. (R), Katalyst (I), Novartis (C), Ophthotech, Corp. (R), Regeneron Pharmaceuticals, Inc. (C), Shire (C)
  • Footnotes
    Support  Genentech, Inc., South San Francisco, CA, provided support for the study and participated in the study design; conducting the study; and data collection, management, and interpretation.
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 1511. doi:
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    • Get Citation

      Brandon Busbee, Jordi Monés, Charles Clifton Wykoff, Giovanni Staurenghi, Fan Tang, Barbara Tong, Ronald A Cantrell, Christopher Brittain, Jason Ehrlich, Hugh Lin, Nancy Holekamp; Understanding the natural history of geographic atrophy secondary to age-related macular degeneration: Baseline data from Proxima A. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1511.

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

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Abstract

Purpose : Geographic atrophy (GA) is an advanced form of age-related macular degeneration leading to significant visual function impairment and eventual blindness. Proxima A (NCT02479386) is a prospective, observational study aimed at better understanding the natural history and disease progression in patients with GA. An interim analysis of baseline (BL) patient characteristics for Proxima A is presented.

Methods : Approximately 360 patients aged ≥50 years with bilateral GA and no choroidal neovascularization are being enrolled at 87 sites globally. Patients will be divided into complement factor I (CFI)-profile genetic biomarker-positive or -negative groups and will be evaluated at 6 month intervals for up to 48 months. The primary outcome measure is GA lesion size evaluated by fundus autofluorescence imaging. Key secondary outcomes include visual function characteristics evaluated by BCVA, monocular reading speed as well as patient-reported outcomes (PROs: NEI Visual Function Questionnaire [VFQ-25] and Functional Reading Independence [FRI] Index).

Results : The planned interim analysis of BL characteristics included all patients enrolled as of August 11, 2016 (N=173). The mean age was 78.1 years, 59% of patients were female, and 98% were white. Nearly half (49%) of patients were positive for the CFI-profile biomarker. The mean BL GA area was 8.07 mm2. The mean number of years since first GA diagnosis was 4.2. Mean BL BCVA was 66.6 ETDRS letters, while mean BL maximum monocular reading speed was 69 wpm. Mean scores were 68.0 for the NEI VFQ-25 and 2.8 for the FRI Index.

Conclusions : Baseline demographic and ocular disease characteristics were consistent with expectations per study enrollment criteria. Baseline visual function data demonstrate the presence of significant functional deficits, highlighting the potential severity and impact of GA on patients’ quality of life. Additional analyses of Proxima A data are planned to continue to advance the understanding of the natural history of GA.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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