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

Publication ,  Journal Article
Jaffe, GJ; Schmitz-Valckenberg, S; Boyer, D; Heier, J; Wolf-Schnurrbusch, U; Staurenghi, G; Schmidt-Erfurth, U; Holz, FG
Published in: Am J Ophthalmol
December 2015

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.

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Published In

Am J Ophthalmol

DOI

EISSN

1879-1891

Publication Date

December 2015

Volume

160

Issue

6

Start / End Page

1226 / 1234

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Serotonin Receptor Agonists
  • Pyrimidines
  • Prospective Studies
  • Piperazines
  • Ophthalmology & Optometry
  • Ophthalmic Solutions
  • Male
  • Macular Degeneration
  • Isoindoles
 

Citation

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Jaffe, G. J., Schmitz-Valckenberg, S., Boyer, D., Heier, J., Wolf-Schnurrbusch, U., Staurenghi, G., … Holz, F. G. (2015). Randomized Trial to Evaluate Tandospirone in Geographic Atrophy Secondary to Age-Related Macular Degeneration: The GATE Study. Am J Ophthalmol, 160(6), 1226–1234. https://doi.org/10.1016/j.ajo.2015.08.024
Jaffe, Glenn J., Steffen Schmitz-Valckenberg, David Boyer, Jeffrey Heier, Ute Wolf-Schnurrbusch, Giovanni Staurenghi, Ursula Schmidt-Erfurth, and Frank G. Holz. “Randomized Trial to Evaluate Tandospirone in Geographic Atrophy Secondary to Age-Related Macular Degeneration: The GATE Study.Am J Ophthalmol 160, no. 6 (December 2015): 1226–34. https://doi.org/10.1016/j.ajo.2015.08.024.
Jaffe GJ, Schmitz-Valckenberg S, Boyer D, Heier J, Wolf-Schnurrbusch U, Staurenghi G, et al. Randomized Trial to Evaluate Tandospirone in Geographic Atrophy Secondary to Age-Related Macular Degeneration: The GATE Study. Am J Ophthalmol. 2015 Dec;160(6):1226–34.
Jaffe, Glenn J., et al. “Randomized Trial to Evaluate Tandospirone in Geographic Atrophy Secondary to Age-Related Macular Degeneration: The GATE Study.Am J Ophthalmol, vol. 160, no. 6, Dec. 2015, pp. 1226–34. Pubmed, doi:10.1016/j.ajo.2015.08.024.
Jaffe GJ, Schmitz-Valckenberg S, Boyer D, Heier J, Wolf-Schnurrbusch U, Staurenghi G, Schmidt-Erfurth U, Holz FG. Randomized Trial to Evaluate Tandospirone in Geographic Atrophy Secondary to Age-Related Macular Degeneration: The GATE Study. Am J Ophthalmol. 2015 Dec;160(6):1226–1234.
Journal cover image

Published In

Am J Ophthalmol

DOI

EISSN

1879-1891

Publication Date

December 2015

Volume

160

Issue

6

Start / End Page

1226 / 1234

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Serotonin Receptor Agonists
  • Pyrimidines
  • Prospective Studies
  • Piperazines
  • Ophthalmology & Optometry
  • Ophthalmic Solutions
  • Male
  • Macular Degeneration
  • Isoindoles