RESUMEN
AIM: This observational study was performed to evaluate the efficacy and safety of intra-vitreal injections of pegaptanib during a 12-month follow-up period. PATIENTS AND METHODS: Forty eyes (20 patients) affected by diabetic macular edema were monitored. Twenty were subjected to treatment, and 20 were controls. The treatment involved a cycle of three intravitreal injections of pegaptanib (0.3 mg every 6 weeks), at the end of which treated patients were submitted to a monthly follow-up for a period of 12 months. The aim was to evaluate the clinical condition of the eye after therapy and gauge the efficacy of the long-term use of this drug. Specific criteria were used to measure the efficacy and safety of pegaptanib. Regarding efficacy, we considered the following: an average improvement in the power of vision, or visual acuity, of â10 letters (2 lines), equivalent to an average logMAR score of â0.2, and a reduction in the central macular thickness of â250 µm. Regarding safety, we considered the occurrence of undesired eye and systemic side effects correlated to either the drug itself or the injection procedure. RESULTS: The logMAR score for the measurement of visual acuity at T3 (third intra-vitreal injection at week 13) with respect to T0 decreased from 0.7 ± 0.277 to 0.445 ± 0.216, suggesting an improvement, while the mean Early Treatment Diabetic Retinopathy Study (ETDRS) score increased from 25.75 ± 13.046 to 34.300 ± 11.770 letters. The central macular thickness was reduced from the initial value of 746.95 ± 293.601 to 334.050 ± 93.997 µm. In seven controls, we registered a worsening both in terms of visual acuity and macular thickness in some eyes, justifying a continuation of therapy in eight eyes of the control group. CONCLUSIONS: Pegaptanib proved to be efficacious and safe for the treatment of diabetic macular edema throughout the 12-month followup. To evaluate its long-term efficacy, further studies are required with larger numbers of patients and longer observational follow-up periods.
Asunto(s)
Aptámeros de Nucleótidos/administración & dosificación , Retinopatía Diabética/tratamiento farmacológico , Edema Macular/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Aptámeros de Nucleótidos/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Inyecciones Intravítreas , Masculino , Persona de Mediana Edad , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIMS: To determine the effectiveness and safety of treatment of intravitreal Ranibizumab for Central Retinal Vein Occlusion. PATIENTS AND METHODS: This non-randomized observational clinical study was comprised of a round of therapy with three IVI. Twenty eyes affected by CRVO were recruited. The average age was 65.06 +/- 15 years and criterion for inclusion: age >18 years, best Corrected Visual Acuity (BCVA) from 5 to 40 letters and macular edema with thickness greater than 275 micrometer. The criteria used for reinjection were: CMT> 150 micrometer, ETDRS <10 letters and LogMAR <0.2. The statistical analysis for continuous variables (ETDRS, logMar and CMT) was conducted calculating median and range (min-max), since these variables, due to sample size, were not normally distributed.Time trends of these variables were plotted with boxplot and differences. Events between T0 and T12 were assessed using the analysis of variance (ANOVA) for repeated measurements and the F test (Pillai's trace). The statistical significance was set at p <=0.05. RESULTS: All of the patients showed improvement. In fact, the ETDRS went from a median of 20.00 to 28.50, LogMAR went from a median of 0.75 to 0.55 and the values for CMT went from a median of 556.00 micrometer to 390.00 micrometer. The drug reaches maximum effectiveness after two months of therapy, with T2 remaining constant from the third injection at T3 until the end of 12 months at T12. CONCLUSIONS: The results produced by our study indicate that Ranibizumab is a valid treatment for CRVO.