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1.
Retina ; 29(1): 38-45, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-18827733

RESUMO

PURPOSE: To evaluate the safety and efficacy of preservative-free triamcinolone (TRIESENCE(R) suspension) for visualization during pars plana vitrectomy. METHODS: This phase III, observer-masked study was conducted in 6 centers by 10 surgeons and enrolled 60 patients undergoing pars plana vitrectomy. Preservative-free triamcinolone (up to 4 mg) was administered to all patients to enhance visualization of vitreous and membranes. During each surgery, video recordings captured visualization pre- and postinstillation of preservative-free triamcinolone. An independent, masked reader evaluated the videos for the degree of visualization using a five-point scale ranging from 0 (not visible) to 4 (clearly delineated). Surgeons used a five-point scale ranging from "strongly disagree" to "strongly agree" to assess whether preservative-free triamcinolone improved visualization. RESULTS: In 59 of 60 cases, the masked reader's scores for visualization of posterior segment structures were higher (i.e., structures were more clearly visible) after instillation of preservative-free triamcinolone. The preinstillation mean visualization score was 0.5 compared to 3.7 postinstillation (P < 0.0001). Greater than 90% of surgeon evaluations agreed or strongly agreed that preservative-free triamcinolone enhanced visualization of posterior segment structures. No safety issues were identified. CONCLUSIONS: Preservative-free triamcinolone (TRIESENCE(R) suspension) was well tolerated and effectively enhanced visualization of posterior segment structures during pars plana vitrectomy.


Assuntos
Membrana Basal/patologia , Glucocorticoides , Triancinolona Acetonida , Vitrectomia , Corpo Vítreo/patologia , Método Duplo-Cego , Oftalmopatias/cirurgia , Feminino , Glucocorticoides/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Conservantes Farmacêuticos , Doenças Retinianas/cirurgia , Suspensões , Resultado do Tratamento , Triancinolona Acetonida/efeitos adversos , Corpo Vítreo/cirurgia
2.
Ophthalmology ; 113(1): 3-13, 2006 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-16368146

RESUMO

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.


Assuntos
Inibidores da Angiogênese/administração & dosagem , Neovascularização de Coroide/tratamento farmacológico , Degeneração Macular/tratamento farmacológico , Fotoquimioterapia , Fármacos Fotossensibilizantes/uso terapêutico , Pregnadienodiois/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/efeitos adversos , Neovascularização de Coroide/etiologia , Neovascularização de Coroide/fisiopatologia , Tecido Conjuntivo/efeitos dos fármacos , Método Duplo-Cego , Feminino , Angiofluoresceinografia , Fóvea Central , Humanos , Degeneração Macular/complicações , Degeneração Macular/fisiopatologia , Masculino , Pessoa de Meia-Idade , Fármacos Fotossensibilizantes/efeitos adversos , Porfirinas/efeitos adversos , Porfirinas/uso terapêutico , Pregnadienodiois/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento , Verteporfina , Acuidade Visual/fisiologia
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