Glenn J Jaffe1, Steffen Schmitz-Valckenberg2, David Boyer3, Jeffrey Heier4, Ute Wolf-Schnurrbusch5, Giovanni Staurenghi6, Ursula Schmidt-Erfurth7, Frank G Holz8. 1. Department of Ophthalmology, Duke Reading Center, Duke University, Durham, North Carolina. 2. Department of Ophthalmology, University of Bonn, Bonn, Germany; GRADE Reading Center, University of Bonn, Bonn, Germany. 3. Retina-Vitreous Associates Medical Group, Beverly Hills, California; University of Southern California, Keck School of Medicine, Los Angeles, California. 4. Ophthalmic Consultants of Boston, Boston, Massachusetts. 5. Bern Photographic Reading Center, Department of Ophthalmology, University Hospital Inselspital and University of Bern, Bern, Switzerland. 6. Eye Clinic, Department of Biomedical and Clinical Science "Luigi Sacco" Sacco Hospital, University of Milan, Milan, Italy. 7. Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. 8. Department of Ophthalmology, University of Bonn, Bonn, Germany; GRADE Reading Center, University of Bonn, Bonn, Germany. Electronic address: Frank.Holz@ukb.uni-bonn.de.
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 withAL-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.
RCT Entities:
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: Benjamin J Kim; Allan Hunter; Alexander J Brucker; Paul Hahn; Karen Gehrs; Apurva Patel; Albert O Edwards; Yafeng Li; Rahul N Khurana; Itzhak Nissim; Ebenezer Daniel; Juan Grunwald; Gui-Shuang Ying; Maxwell Pistilli; Maureen G Maguire; Joshua L Dunaief Journal: Ophthalmol Retina Date: 2020-04-02
Authors: Kimberly J Cocce; Sandra S Stinnett; Ulrich F O Luhmann; Lejla Vajzovic; Anupama Horne; Stefanie G Schuman; Cynthia A Toth; Scott W Cousins; Eleonora M Lad Journal: Am J Ophthalmol Date: 2018-03-15 Impact factor: 5.258
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