title: Randomized Trial to Evaluate Tandospirone in Geographic Atrophy Secondary to Age-Related Macular Degeneration: The GATE Study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Prospective, controlled, double-masked, randomized, multicenter phase 3 clinical trial.
  
  
  METHODS
  setting: Forty-eight clinical sites.
  
  
  METHODS
  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.
  
  
  METHODS
  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: Department of Ophthalmology, Duke Reading Center, Duke University, Durham, North Carolina.
authors: Glenn J
authors: GJ
authors: Jaffe
authors: Department of Ophthalmology, University of Bonn, Bonn, Germany; GRADE Reading Center, University of Bonn, Bonn, Germany.
authors: Steffen
authors: S
authors: Schmitz-Valckenberg
authors: Retina-Vitreous Associates Medical Group, Beverly Hills, California; University of Southern California, Keck School of Medicine, Los Angeles, California.
authors: David
authors: D
authors: Boyer
authors: Ophthalmic Consultants of Boston, Boston, Massachusetts.
authors: Jeffrey
authors: J
authors: Heier
authors: Bern Photographic Reading Center, Department of Ophthalmology, University Hospital Inselspital and University of Bern, Bern, Switzerland.
authors: Ute
authors: U
authors: Wolf-Schnurrbusch
authors: Eye Clinic, Department of Biomedical and Clinical Science "Luigi Sacco" Sacco Hospital, University of Milan, Milan, Italy.
authors: Giovanni
authors: G
authors: Staurenghi
authors: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
authors: Ursula
authors: U
authors: Schmidt-Erfurth
authors: Department of Ophthalmology, University of Bonn, Bonn, Germany; GRADE Reading Center, University of Bonn, Bonn, Germany. Electronic address: Frank.Holz@ukb.uni-bonn.de.
authors: Frank G
authors: FG
authors: Holz
mesh_terms: D000368:Aged; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D057092:Geographic Atrophy / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D054833:Isoindoles / Q000008:administration & dosage*; D008268:Macular Degeneration / Q000150:complications* / Q000175:diagnosis; D008297:Male; D009883:Ophthalmic Solutions; D010879:Piperazines / Q000008:administration & dosage*; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage*; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D054833:Isoindoles; D009883:Ophthalmic Solutions; D010879:Piperazines; D011743:Pyrimidines; D017366:Serotonin Receptor Agonists; C055267:tandospirone