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 had a ≥ 15-letter improvement at day 98.Conclusions:Repeated intravitreal injections of ranibizumab had a good safety profile and were associated with improved VA and decreased leakage from choroidal neovascularization in subjects with neovascularAMD.
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