April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
Topical OT-551 for Treating Geographic Atrophy: Phase II Results
Author Affiliations & Notes
  • P. Sternberg
    Ophthal & Vis Sci, Vanderbilt Eye Institute, Nashville, Tennessee
  • P. J. Rosenfeld
    Bascom Palmer Eye Institute, Univ of Miami Miller Sch of Med, Miami, Florida
  • J. S. Slakter
    Vitreous Retina Macula Consultants NY, New York, New York
  • J. M. Koester
    Clinical Dvlpmt, Othera Pharmaceuticals, Inc, Exton, Pennsylvania
  • A. Reaves
    Clinical Dvlpmt, Othera Pharmaceuticals, Inc, Exton, Pennsylvania
  • Footnotes
    Commercial Relationships  P. Sternberg, Othera Pharmaceuticals, F; Othera Pharmaceuticals, C; P.J. Rosenfeld, Othera Pharmaceuticals, Quark, CoMentis, Potentia, Zeiss Meditec, Alexion, F; Othera, CoMentis, Glaxo SmithKline, Sanofi-Aventis, Oraya, Potentia, C; J.S. Slakter, Othera Pharmaceuticals, Sirion, F; J.M. Koester, Othera Pharmaceuticals, E; A. Reaves, Othera Pharmaceuticals, E.
  • Footnotes
    Support  Othera Pharmaceuticals
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 6416. doi:
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      P. Sternberg, P. J. Rosenfeld, J. S. Slakter, J. M. Koester, A. Reaves; Topical OT-551 for Treating Geographic Atrophy: Phase II Results. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6416.

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

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Purpose: : To determine if treatment with OT-551 reduces progression of the the area of geographic atrophy (GA) in subjects with GA associated with age-related macular degeneration (AMD).

Methods: : A randomized, double-masked, multi-center, placebo-controlled, clinical trial of OT-551 (0.3% & 0.45%) in 137 subjects with GA was performed. The study eye was required to have ≥1 discrete areas of GA of ≥1.3 mm2 (0.5 disc area [DA]) and a total GA area of 1.3 to 17.8 mm2 (0.5 - 7.0 DA) that is within 3000 microns of the foveal center. Topical OT-551 was administered to only one qualifying eye 4X daily for up to 2 years. Visits were scheduled at screening, baseline (BL), and at 1, 3, 6, 9, 12, 15, 18, 21 & 24 months. Efficacy outcomes included changes from BL in total area of GA and best-corrected visual acuity (BCVA) score. Safety measures were assessed by complete ophthalmologic examination and review of ocular and systemic adverse events (AEs).

Results: : At BL, the mean (median) area of GA in study eyes from digital fluorescein angiograms was 6.17 (6.26) mm2 in the vehicle placebo group, 6.26 (5.72) mm2 in the OT-551 0.3% group, and 6.04 (5.11) mm2 in the OT-551 0.45% group. At month 18, mean (median) changes from BL of +3.55 (+3.08)mm2 in the placebo group, +3.01 (+2.91) mm2 in the OT-551 0.3% group, and +3.43 (+2.70) mm2 in the OT-551 0.45% group were observed. Mean (median) changes in BCVA at 18 months in study eyes were -4.9 (-3.0) letters in the placebo group, -8.9 (-6.0) letters in the OT-551 0.3% group, and -7.7 (-5.0) letters in the OT-551 0.45% group. The proportion of subjects losing ≥15 letters at month 18 was 16% in the placebo group, 20% in the OT-551 0.3% group and 21% in the OT-551 0.45% group. Most reported AEs were non-serious, mild in severity, and occurred at a low incidence (<5%). All serious AEs were non-ocular and none were related to the study drug.

Conclusions: : While concentrations of OT-551 up to 0.45% appear to be safe when dosed 4X daily for up to two years, OT-551 does not appear to reduce the progression of the area of GA in subjects with AMD.

Clinical Trial: : www.clinicaltrials.gov NCT00485394

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • antioxidants 

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