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W. T. Wong, W. Kam, D. Cunningham, E. Y. Chew, F. L. Ferris, III; Topical Administration of Anti-Oxidant, OT-551 for the Treatment of Geographic Atrophy: Results of a Phase I/II Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6418.
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To investigate the safety and preliminary efficacy of OT-551, an anti-oxidant compound, for the treatment of geographic atrophy (GA), the advanced atrophic form of age-related macular degeneration (AMD).
A single center, open-label, prospective, unilaterally-administered, phase I/II clinical trial, enrolling 10 participants with bilateral GA, was performed. Topical 0.45% OT-551 was administered in only one randomly assigned "study eye" three times daily for a period of 2 years. The untreated fellow eyes served as controls. Safety measures were assessed by complete ophthalmologic examination, fundus photography, and review of ocular and systemic symptoms at 1, 3, 6, 9, 12, 18, and 24 months. The primary efficacy outcome measure was the change in best-corrected visual acuity (BCVA) at 24 months. Secondary efficacy measures included change, from baseline, in area of GA, progression to neovascular AMD, change in contrast sensitivity, change in microperimetry measurements, and change in baseline drusen area.
Study drug was well tolerated and was associated with few adverse ocular and systemic adverse events. Mean change in BCVA at 2 years in study eyes was +0.2±13.3 letters, while that in fellow eyes was -11.3±7.6 letters (p = 0.0259). The proportions of participants losing ≥5 letters,≥10 letters, ≥15 letters compared to baseline were lower for the study eye than the fellow eye at all time-points. No statistically significant differences at 2 years were however found between study and fellow eyes for change in baseline area of GA, progression to neovascular AMD, change in contrast sensitivity, change in microperimetry measurements, or change in baseline drusen area.
OT-551 is a well-tolerated, topical agent with no apparent serious adverse effects. Preliminary efficacy measurements indicate a possible effect in maintaining visual acuity in treated eyes. However, the absence of significant effects on the rate of GA lesion enlargement indicates the need for further study concerning the efficacy of OT-551 as a treatment for GA.
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