RESUMEN
OBJECTIVE: To report the 12-month results of the first head-to-head comparison of a dexamethasone implant (Ozurdex; Allergan, Inc., Irvine, CA) versus bevacizumab (Avastin; Genentech, South San Francisco, CA) for center-involving diabetic macular edema (DME). DESIGN: Phase 2, prospective, multicenter, randomized, single-masked clinical trial (clinicaltrials.gov identifier NCT01298076). PARTICIPANTS: We enrolled 88 eyes of 61 patients with center-involving DME. METHODS: Forty-two eyes were randomized to receive bevacizumab every 4 weeks and 46 eyes were randomized to receive a dexamethasone implant every 16 weeks, both pro re nata. Results were analyzed using linear regression with generalized estimation equation methods to account for between-eye correlation. MAIN OUTCOME MEASURES: The primary outcome was the proportion of eyes that improved vision by 10 logarithm of minimum angle of resolution letters. Secondary outcomes included mean change in best-corrected visual acuity (BCVA), change in central macular thickness (CMT), injection frequency, and adverse events. Patient-reported outcomes were measured using the Impact of Vision Impairment (IVI) questionnaire. RESULTS: Improvement in BCVA of 10 or more letters was found in 17 of 42 eyes (40%) treated with bevacizumab compared with 19 of 46 dexamethasone implant-treated eyes (41%; P = 0.83). None of the 42 bevacizumab eyes lost 10 letters or more, whereas 5 of 46 (11%) dexamethasone implant eyes did, mostly because of cataract. Mean CMT decreased by 122 µm for bevacizumab eyes and by 187 µm for dexamethasone implant eyes (P = 0.015). Bevacizumab-treated eyes received a mean of 8.6 injections compared with 2.7 injections for dexamethasone implant eyes. Significant improvement in IVI scores occurred for both treatment groups. CONCLUSIONS: Dexamethasone implant achieved similar rates of visual acuity improvement compared with bevacizumab for DME, with superior anatomic outcomes and fewer injections. Both treatments were associated with improvement in visual quality-of-life scores. However, more dexamethasone implant-treated eyes lost vision, mainly because of cataract.
Asunto(s)
Inhibidores de la Angiogénesis/administración & dosificación , Antiinflamatorios/administración & dosificación , Anticuerpos Monoclonales Humanizados/administración & dosificación , Dexametasona/administración & dosificación , Retinopatía Diabética/tratamiento farmacológico , Edema Macular/tratamiento farmacológico , Anciano , Bevacizumab , Preparaciones de Acción Retardada/uso terapéutico , Retinopatía Diabética/fisiopatología , Implantes de Medicamentos , Femenino , Humanos , Inyecciones Intravítreas , Mácula Lútea/patología , Edema Macular/etiología , Edema Macular/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Análisis de Regresión , Encuestas y Cuestionarios , Agudeza Visual/fisiologíaAsunto(s)
Glaucoma/inducido químicamente , Presión Intraocular/efectos de los fármacos , Degeneración Macular/tratamiento farmacológico , Ranibizumab/efectos adversos , Tonometría Ocular/métodos , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/administración & dosificación , Inhibidores de la Angiogénesis/efectos adversos , Femenino , Glaucoma/diagnóstico , Glaucoma/fisiopatología , Humanos , Degeneración Macular/diagnóstico , Degeneración Macular/fisiopatología , Masculino , Ranibizumab/administración & dosificación , Reproducibilidad de los Resultados , Estudios RetrospectivosRESUMEN
The benchmark treatment for diabetic macular oedema, the major cause of visual impairment in patients with diabetes mellitus, has traditionally been laser photocoagulation; however, as laser treatment does not always improve vision or even prevent further loss in many cases, several new pharmacotherapies that are injected into the vitreous for diabetic macular oedema have been successfully trialled over the past decade. Others are currently being evaluated. The two major classes of these drugs are steroids and vascular endothelial growth factor antagonists. In this article we briefly review the major clinical studies recently conducted in this field.