June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Baseline Characteristics of BAM114341 population, a Phase II study in geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD)
Author Affiliations & Notes
  • Shawn Patrick Shearn
    Ophthalmology, GSK, King of Prussia, PA
  • Mike Fries
    Ophthalmology, GSK, King of Prussia, PA
  • John I Wurzelmann
    Ophthalmology, GSK, King of Prussia, PA
  • Francisco J Lopez
    Ophthalmology, GSK, King of Prussia, PA
  • Michael R Schwartz
    Ophthalmology, GSK, King of Prussia, PA
  • Rabia Ozden
    Ophthalmology, GSK, King of Prussia, PA
  • Baruch Kuppermann
    The Gavin Herbert Eye Institute, University of California, Irvine, Irvine, CA
  • Footnotes
    Commercial Relationships Shawn Shearn, GSK (E); Mike Fries, GSK (E); John Wurzelmann, GSK (E); Francisco Lopez, GSK (E); Michael Schwartz, GSK (E); Rabia Ozden, GSK (E); Baruch Kuppermann, AcuFocus, Aerpio (C), Alcon, Alimera (C), Alcon, Allegro, Allergan (F), Allegro, Allergan (C), Ampio (C), Genentech (F), Genetech (C), GSK (F), Neurotech (C), Neurotech, Ophthotech (F), Novartis (C), Ophthotech (C), Regeneron (C), Regeneron, ThromboGenics (F), SecondSight (C), Staar Surgical (C), Teva (C), ThromboGenics (C)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 2840. doi:
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      Shawn Patrick Shearn, Mike Fries, John I Wurzelmann, Francisco J Lopez, Michael R Schwartz, Rabia Ozden, Baruch Kuppermann, ; Baseline Characteristics of BAM114341 population, a Phase II study in geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):2840.

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

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Abstract
 
Purpose
 

To describe baseline characteristics of the BAM114341 study population.

 
Methods
 

BAM114341 is a double masked, placebo-controlled clinical study to investigate the safety and efficacy of a humanized monoclonal antibody directed against β-amyloid in patients with GA secondary to AMD. The ongoing study included a 4-month run-in observation period where baseline growth rates of GA lesions were established to use pre-treatment patient-specific growth rates for comparison with those after randomization for a period of 18 months. It randomized 191 patients with a GA total area of 1.9 - 17 mm2 at the screening visit. Monthly measures of GA lesion size by color fundus photography (CP) and fundus autofluorescence (FAF) were taken for the run-in period. A mixed effects model was created to estimate GA lesion growth rate. The demographics of the study population, the model estimate of the GA lesion growth rate and the concordance of the CP and FAF measurements evaluated by Bland-Altman analysis are described.

 
Results
 

The average age at screening was 77.2 years (range, 55-95 years, SD 8.6 years), and 57% of the cohort was female. Average baseline BCVA was 62.7 (SD=14.8) letters. 85% of patients had bilateral GA and 59% of patients had study eye central involvement. The average GA lesion size at screening in the study eye by CP was 7.72 mm2 (SD 4.52 mm2). The average change in GA lesion size during the run-in was estimated as 0.78 mm2 (95% CI 0.57-0.98 mm2) and 0.76 mm2 (95% CI 0.61-0.92 mm2) for CP and FAF, respectively. Model based growth rates for CP and FAF in the run-in period were 0.66 mm2 and 0.64 mm2. These values extrapolate to annualized growth rates of 2.16 mm2 (95% CI 1.75-2.54 mm2) and 2.06 mm2 (95% CI 1.70-2.41 mm2) for CP and FAF, respectively. These are consistent with values reported in the literature; i.e. Sunness, et al (Ophthalmology 2007;114:271-277) reported 2.6 mm2 per year for CP and Holz, et al (IOVS 2011;52:6552-6557) 1.64 mm2 for FAF. Moreover,the CP and FAF measurements showed agreement (average difference 0.11 mm2, SD 1.37 mm2, with 95% limits of agreement of -2.80 mm2, 2.54 mm2).

 
Conclusions
 

The BAM114341 measurements by CP and FAF over the 4 month observation period were in agreement, and the estimated growth rate reflects other GA cohorts in the literature.

 
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