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

Published

Journal Article

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.Prospective, controlled, double-masked, randomized, multicenter phase 3 clinical trial.setting: Forty-eight clinical sites.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.The primary efficacy endpoint was mean annualized lesion enlargement from baseline as assessed with fundus autofluorescence (FAF) imaging.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.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.

Full Text

Duke Authors

Cited Authors

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

Published Date

  • December 2015

Published In

Volume / Issue

  • 160 / 6

Start / End Page

  • 1226 - 1234

PubMed ID

  • 26310670

Pubmed Central ID

  • 26310670

Electronic International Standard Serial Number (EISSN)

  • 1879-1891

International Standard Serial Number (ISSN)

  • 0002-9394

Digital Object Identifier (DOI)

  • 10.1016/j.ajo.2015.08.024

Language

  • eng