当前位置： SCI文献检索 > AMERICAN JOURNAL OF OPHTHALMOLOGY期刊下所有文献 > Randomized Trial to Evaluate Tandospirone in Geographic Atrophy Secondary to Age-Related Macular Degeneration: The GATE Study.

Randomized Trial to Evaluate Tandospirone in Geographic Atrophy Secondary to Age-Related Macular Degeneration: The GATE Study.

Abstract：

PURPOSE:To determine the safety and efficacy of AL-8309B (tandospirone) in the management of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) and obtain standardized data on GA lesion growth progression. DESIGN:Prospective, controlled, double-masked, randomized, multicenter phase 3 clinical trial. METHODS:setting: Forty-eight clinical sites. PATIENTS:Patients with GA associated with AMD were enrolled. All patients were followed for a minimum of 30 months, and up to 36 months. intervention procedures: Patients were randomized (1:1:1) to receive AL-8309B ophthalmic solution 1.0%, 1.75%, or vehicle, administered as a twice-daily topical ocular drop. MAIN OUTCOME MEASURES:The primary efficacy endpoint was mean annualized lesion enlargement from baseline as assessed with fundus autofluorescence (FAF) imaging. RESULTS:A total of 768 eyes of 768 patients were enrolled and treated with AL-8309B 1.0% (n = 250), AL-8309B 1.75% (n = 258), or vehicle (n = 260). An increase in mean lesion size was observed in both the AL-8309B and vehicle treatment groups, and growth rates were similar in all treatment groups. Annualized lesion growth rates were 1.73, 1.76, and 1.71 mm(2) for AL-8309B 1.0%, AL-8309B 1.75%, and vehicle, respectively. CONCLUSIONS:AL-8309B 1.0% and 1.75% did not affect lesion growth in eyes with GA secondary to AMD. There were no clinically relevant safety issues identified for AL-8309B. The large natural history dataset from this study is a valuable repository for future comparisons.

journal_name

Am J Ophthalmol

journal_title

American journal of ophthalmology

authors

Jaffe GJ,Schmitz-Valckenberg S,Boyer D,Heier J,Wolf-Schnurrbusch U,Staurenghi G,Schmidt-Erfurth U,Holz FG

doi

10.1016/j.ajo.2015.08.024

subject

Has Abstract

pub_date

2015-12-01 00:00:00

pages

1226-34

issue

6

eissn

0002-9394

issn

1879-1891

pii

S0002-9394(15)00518-8

journal_volume

160

pub_type

杂志文章,多中心研究,随机对照试验

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