Jaffe Glenn J, Schmitz-Valckenberg Steffen, Boyer David, Heier Jeffrey, Wolf-Schnurrbusch Ute, Staurenghi Giovanni, Schmidt-Erfurth Ursula, Holz Frank G
Department of Ophthalmology, Duke Reading Center, Duke University, Durham, North Carolina.
Department of Ophthalmology, University of Bonn, Bonn, Germany; GRADE Reading Center, University of Bonn, Bonn, Germany.
Am J Ophthalmol. 2015 Dec;160(6):1226-34. doi: 10.1016/j.ajo.2015.08.024. Epub 2015 Aug 24.
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.
确定AL-8309B（坦度螺酮）治疗年龄相关性黄斑变性（AMD）继发地图样萎缩（GA）患者的安全性和有效性，并获取GA病变生长进展的标准化数据。
前瞻性、对照、双盲、随机、多中心3期临床试验。
地点：48个临床地点。
纳入患有AMD相关GA的患者。所有患者至少随访30个月，最长随访36个月。干预措施：患者随机（1:1:1）接受1.0%、1.75%的AL-8309B眼药水或赋形剂，每日两次局部滴眼给药。
主要疗效终点是通过眼底自发荧光（FAF）成像评估的自基线起平均年化病变扩大情况。
共纳入768例患者的768只眼，分别用1.0%的AL-8309B（n = 250）、1.75%的AL-8309B（n = 258）或赋形剂（n = 260）进行治疗。在AL-8309B组和赋形剂治疗组中均观察到平均病变大小增加，且所有治疗组的生长率相似。1.0%的AL-8309B组、1.75%的AL-8309B组和赋形剂组的年化病变生长率分别为1.73、1.76和1.71mm²。
1.0%和1.75%的AL-8309B不影响AMD继发GA患者眼睛的病变生长。未发现与AL-8309B相关的临床安全性问题。本研究的大型自然病史数据集是未来比较的宝贵资源。
