Purpose:To investigate complications associated with ganciclovir implants used to treat AIDS-related cytomegalovirus(CMV)retinitis,and to identify factors that predict poor outcomes.Design:Retrospective chart review.P...Purpose:To investigate complications associated with ganciclovir implants used to treat AIDS-related cytomegalovirus(CMV)retinitis,and to identify factors that predict poor outcomes.Design:Retrospective chart review.Participants:Consecutive patients with AIDS-related CMV retinitis from 3 clinical facilities who underwent implantation procedures during the period January 1,1995 through December 31,2001.Methods:Baseline for each patient was the date of the first implantation procedure performed during the study period by one of the facilities’surgeons(index implant).Medical and ophthalmological data were collected at baseline and at specific time points after baseline.The dates on which additional implantation procedures were performed and the dates on which complications or vision loss were identified were also recorded.Relationships between potential risk factors and outcomes were studied by Kaplan-Meier analyses and Cox proportional hazards regression models.Main Outcome Measures:Primary outcome measures included postoperative complications specifically related to or possibly related to ganciclovir implants.A secondary outcome measure was vision loss after implantation procedures.Results:The charts of 174 patients(one study eye per patient;279 implants)were reviewed.Median follow-up was 14.4 months(range,0-7 years).Complications specifically related to implants occurred throughout follow-up at a rate of 0.064 events per patient-year.Complications possibly related to implants occurred at an overall rate of 0.377 per patient-year,but seemed to be more common during the first 2 years after baseline.During the first 2 years of followup,retinal detachments occurred at a rate of 0.156 events per patient-year.The cumulative risk of vision loss(≥ 3 lines of Snellen visual acuity)at 7 years was 70%.Poor outcomes were associated with disease factors(size and activity of lesions),lack of highly active antiretroviral therapy(HAART),and lack of HAART-associated immune reconstitution,but not with surgical factors or impla展开更多
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.Desi...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 展开更多
文摘Purpose:To investigate complications associated with ganciclovir implants used to treat AIDS-related cytomegalovirus(CMV)retinitis,and to identify factors that predict poor outcomes.Design:Retrospective chart review.Participants:Consecutive patients with AIDS-related CMV retinitis from 3 clinical facilities who underwent implantation procedures during the period January 1,1995 through December 31,2001.Methods:Baseline for each patient was the date of the first implantation procedure performed during the study period by one of the facilities’surgeons(index implant).Medical and ophthalmological data were collected at baseline and at specific time points after baseline.The dates on which additional implantation procedures were performed and the dates on which complications or vision loss were identified were also recorded.Relationships between potential risk factors and outcomes were studied by Kaplan-Meier analyses and Cox proportional hazards regression models.Main Outcome Measures:Primary outcome measures included postoperative complications specifically related to or possibly related to ganciclovir implants.A secondary outcome measure was vision loss after implantation procedures.Results:The charts of 174 patients(one study eye per patient;279 implants)were reviewed.Median follow-up was 14.4 months(range,0-7 years).Complications specifically related to implants occurred throughout follow-up at a rate of 0.064 events per patient-year.Complications possibly related to implants occurred at an overall rate of 0.377 per patient-year,but seemed to be more common during the first 2 years after baseline.During the first 2 years of followup,retinal detachments occurred at a rate of 0.156 events per patient-year.The cumulative risk of vision loss(≥ 3 lines of Snellen visual acuity)at 7 years was 70%.Poor outcomes were associated with disease factors(size and activity of lesions),lack of highly active antiretroviral therapy(HAART),and lack of HAART-associated immune reconstitution,but not with surgical factors or impla
文摘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
