兰尼单抗治疗新生血管性老年性黄斑变性的Ⅰ/Ⅱ期多中心临床对照多剂量研究  

Ranibizumab for Treatment of Neovascular Age-Related Macular Degeneration. A Phase I/II Multicenter,Controlled,Multidose Study

作　　者：Heier J.S. Antoszyk A.N. Pavan P.R. 刑咏新 

机构地区：[1]Ophthalmic Consultants of Boston,Boston,MA,United States Dr.

出　　处：《世界核心医学期刊文摘（眼科学分册）》2006年第10期50-51,共2页Digest of the World Core Medical Journals:Ophthalmology

摘　　要：Objective:To assess safety of repeated intravitreal injections of ranibizumab in treating neovascular age-related macular degeneration(AMD),and to assess changes in visual acuity(VA)and AMD lesion characteristics.Design:Multicenter,controlled,open-label,clinical trial.Participants:Sixty-four patients with subfoveal predominantly or minimally classic AMD-related choroidal neovascularization.Methods:In part 1,subjects were randomized to monthly intravitreal ranibizumab for 3 months(4 injections of 0.3 mg or 1 injection of 0.3 mg followed by 3 injections of 0.5 mg;n=53)or usual care(UC;n=11).In part 2,subjects could continue their regimen for 3 additional months or cross over to the alternative treatment.Main Outcome Measures:Adverse events(AEs),intraocular pressure(IOP),VA,and lesion characteristics assessed by fluorescein angiography and fundus photography.Results:Of the 64 randomized subjects,62 completed the 6-month study.Twenty of 25 subjects(80%)randomized to 0.3 mg,and 22 of 28 subjects(79%)randomized to 0.5-mg ranibizumab in part 1 continued on that treatment in part 2;9 of 11(82%)subjects randomized to UC in part 1 crossed over to ranibizumab treatment in part 2.The most common AEs with ranibizumab were reversible inflammation and minor injection-site hemorrhages.Serious AEs were iridocyclitis,endophthalmitis,and central retinal vein occlusion(1 subject each).Postinjection,IOP increased transiently in 22.6% of ranibizumab-treated eyes in parts 1 and 2.After 4 ranibizumab injections(day 98),mean(± standard deviation)VA had increased 9.4± 13.3 and 9.1± 17.2 letters in the 0.3-and 0.5-mg groups,respectively,but had decreased 5.1± 9.6 letters with UC.In part 2(day 210),VA increased from baseline 12.8± 14.7 and 15.0± 14.2 letters in subjects continuing on 0.3 and 0.5 mg,respectively.Visual acuity improved from baseline ≥ 15 letters in 26%(day 98)and 45%(day 210)of subjects initially randomized to and continuing on ranibizumab,respectively,and areas of leakage and subretinal fluid decreased.No UC subject Objective:To assess safety of repeated intravitreal injections of ranibizumab in treating neovascular age-related macular degeneration(AMD),and to assess changes in visual acuity(VA)and AMD lesion characteristics.Design:Multicenter,controlled,open-label,clinical trial.Participants:Sixty-four patients with subfoveal predominantly or minimally classic AMD-related choroidal neovascularization.Methods:In part 1,subjects were randomized to monthly intravitreal ranibizumab for 3 months(4 injections of 0.3 mg or 1 injection of 0.3 mg followed by 3 injections of 0.5 mg;n=53)or usual care(UC;n=11).In part 2,subjects could continue their regimen for 3 additional months or cross over to the alternative treatment.Main Outcome Measures:Adverse events(AEs),intraocular pressure(IOP),VA,and lesion characteristics assessed by fluorescein angiography and fundus photography.Results:Of the 64 randomized subjects,62 completed the 6-month study.Twenty of 25 subjects(80%)randomized to 0.3 mg,and 22 of 28 subjects(79%)randomized to 0.5-mg ranibizumab in part 1 continued on that treatment in part 2;9 of 11(82%)subjects randomized to UC in part 1 crossed over to ranibizumab treatment in part 2.The most common AEs with ranibizumab were reversible inflammation and minor injection-site hemorrhages.Serious AEs were iridocyclitis,endophthalmitis,and central retinal vein occlusion(1 subject each).Postinjection,IOP increased transiently in 22.6% of ranibizumab-treated eyes in parts 1 and 2.After 4 ranibizumab injections(day 98),mean(± standard deviation)VA had increased 9.4± 13.3 and 9.1± 17.2 letters in the 0.3-and 0.5-mg groups,respectively,but had decreased 5.1± 9.6 letters with UC.In part 2(day 210),VA increased from baseline 12.8± 14.7 and 15.0± 14.2 letters in subjects continuing on 0.3 and 0.5 mg,respectively.Visual acuity improved from baseline ≥ 15 letters in 26%(day 98)and 45%(day 210)of subjects initially randomized to and continuing on ranibizumab,respectively,and areas of leakage and subretinal fluid decreased.No UC subject

关 键 词：老年性黄斑变性 单抗治疗 玻璃体内注射 眼底照相 病变特征 荧光血管造影 临床对照试验 视网膜下积液 

分 类 号：R774.5[医药卫生—眼科]