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.

• Authors: Glenn J Jaffe, Steffen Schmitz-Valckenberg, David Boyer, Jeffrey Heier, Ute Wolf-Schnurrbusch, Giovanni Staurenghi, Ursula Schmidt-Erfurth, Frank G Holz
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 160 Issue 6 Pg. 1226-34 (Dec 2015) ISSN: 1879-1891 [Electronic] United States
• PMID: 26310670 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Isoindoles
• Ophthalmic Solutions
• Piperazines
• Pyrimidines
• Serotonin Receptor Agonists
• tandospirone

Topics

• Aged
• Disease Progression
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Fluorescein Angiography
• Follow-Up Studies
• Fundus Oculi
• Geographic Atrophy (diagnosis, drug therapy, etiology)
• Humans
• Isoindoles (administration & dosage)
• Macular Degeneration (complications, diagnosis)
• Male
• Ophthalmic Solutions
• Piperazines (administration & dosage)
• Prospective Studies
• Pyrimidines (administration & dosage)
• Serotonin Receptor Agonists (administration & dosage)
• Treatment Outcome