PURPOSE: To compare 1-year safety and efficacy of anecortave acetate 15 mg with photodynamic therapy (PDT) with verteporfin in patients eligible for initial PDT treatment. Design: Prospective, masked, randomized, mult...PURPOSE: To compare 1-year safety and efficacy of anecortave acetate 15 mg with photodynamic therapy (PDT) with verteporfin in patients eligible for initial PDT treatment. Design: Prospective, masked, randomized, multicenter, parallel group, active control, noninferiority clinical trial. Participants: Five hundred thirty patients with predominantly classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized to treatment with either anecortave acetate 15 mg or PDT. Methods: In the anecortave acetate group, the drug was administered under the Tenon’s capsule as a periocular posterior juxtascleral depot (PJD) at the beginning of the study and at month 6. Before the first administration of anecortave acetate, patients in this treatment group received a sham PDT treatment, and sham PDT treatments were repeated every 3 months if there was evidence of leakage on fluorescein angiography (FA). Patients assigned to PDT received up to 4 PDT treatments at 3-month intervals, as needed based upon FA, and a sham PJD procedure at the beginning of the study and at month 6. Best-corrected visual acuity was determined at baseline and all follow-up visits. Safety data were regularly reviewed by an independent safety committee. Main Outcome Measure: Percent responders (patients losing <3 lines of vision) at month 12. Results: Percent responders in the anecortave acetate and PDT groups were 45%and 49%, respectively (not statistically different, P=0.43). The confidence interval (CI) for the difference ranged from -13.2%favoring PDT to+5.6%favoring anecortave acetate. The month 12 clinical outcome for anecortave acetate was improved in patients for whom reflux was controlled and who were treated within the 6-month treatment window (57%vs. 49%; 95%CI,-4.3%favoring PDT to+21.7%favoring anecortave acetate). No serious adverse events related to the study drug were reported in either treatment group. Conclusions: The safety and efficacy outcomes in this study demonstrate that the benefits of anecortave acetate for the treatment of choroidal neovascularization outweigh the risks associated with either the drug or the PJD administration procedure.展开更多
PURPOSE: To report a case of bilateral diffuse uveal melanocytic proliferation (BDUMP) that had areas of retinal pigment epithelial loss. DESIGN: Observational case report. METHODS: A 67-year-old woman with a history ...PURPOSE: To report a case of bilateral diffuse uveal melanocytic proliferation (BDUMP) that had areas of retinal pigment epithelial loss. DESIGN: Observational case report. METHODS: A 67-year-old woman with a history of uterine cancer presented with 4 months of bilateral visual loss. RESULTS: Although B-scan ultrasonography revealed both small shallow serous retinal and choroidal detachments in the periphery, the choroid was normal in thickness. Fluorescein angiography revealed numerous nummular-shaped areas of transmission defects suggesting retinal pigment epithelium loss. Autofluorescence photography showed complete absence of autofluorescence in these nummular areas, and optical co-herence tomography showed segmental areas with lack of any signal from affected areas of the retinal pigment epithelium, suggesting complete loss of retinal pigment epithelium cells. CONCLUSIONS: Although the fundus findings in BDUMPhave been attributed to the proliferation of uveal melanocytic cells in the outer choroid in previous papers, our patient had nummular areas of loss of the retinal pigment epithelium as the apparent reason for visual decline.展开更多
文摘PURPOSE: To compare 1-year safety and efficacy of anecortave acetate 15 mg with photodynamic therapy (PDT) with verteporfin in patients eligible for initial PDT treatment. Design: Prospective, masked, randomized, multicenter, parallel group, active control, noninferiority clinical trial. Participants: Five hundred thirty patients with predominantly classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized to treatment with either anecortave acetate 15 mg or PDT. Methods: In the anecortave acetate group, the drug was administered under the Tenon’s capsule as a periocular posterior juxtascleral depot (PJD) at the beginning of the study and at month 6. Before the first administration of anecortave acetate, patients in this treatment group received a sham PDT treatment, and sham PDT treatments were repeated every 3 months if there was evidence of leakage on fluorescein angiography (FA). Patients assigned to PDT received up to 4 PDT treatments at 3-month intervals, as needed based upon FA, and a sham PJD procedure at the beginning of the study and at month 6. Best-corrected visual acuity was determined at baseline and all follow-up visits. Safety data were regularly reviewed by an independent safety committee. Main Outcome Measure: Percent responders (patients losing <3 lines of vision) at month 12. Results: Percent responders in the anecortave acetate and PDT groups were 45%and 49%, respectively (not statistically different, P=0.43). The confidence interval (CI) for the difference ranged from -13.2%favoring PDT to+5.6%favoring anecortave acetate. The month 12 clinical outcome for anecortave acetate was improved in patients for whom reflux was controlled and who were treated within the 6-month treatment window (57%vs. 49%; 95%CI,-4.3%favoring PDT to+21.7%favoring anecortave acetate). No serious adverse events related to the study drug were reported in either treatment group. Conclusions: The safety and efficacy outcomes in this study demonstrate that the benefits of anecortave acetate for the treatment of choroidal neovascularization outweigh the risks associated with either the drug or the PJD administration procedure.
文摘PURPOSE: To report a case of bilateral diffuse uveal melanocytic proliferation (BDUMP) that had areas of retinal pigment epithelial loss. DESIGN: Observational case report. METHODS: A 67-year-old woman with a history of uterine cancer presented with 4 months of bilateral visual loss. RESULTS: Although B-scan ultrasonography revealed both small shallow serous retinal and choroidal detachments in the periphery, the choroid was normal in thickness. Fluorescein angiography revealed numerous nummular-shaped areas of transmission defects suggesting retinal pigment epithelium loss. Autofluorescence photography showed complete absence of autofluorescence in these nummular areas, and optical co-herence tomography showed segmental areas with lack of any signal from affected areas of the retinal pigment epithelium, suggesting complete loss of retinal pigment epithelium cells. CONCLUSIONS: Although the fundus findings in BDUMPhave been attributed to the proliferation of uveal melanocytic cells in the outer choroid in previous papers, our patient had nummular areas of loss of the retinal pigment epithelium as the apparent reason for visual decline.
