RESUMEN
Importance: Macular edema (ME) is the leading cause of decreased visual acuity (VA) associated with retinal vein occlusion (RVO). Identifying factors associated with better outcomes in RVO eyes treated with anti-vascular endothelial growth factor (VEGF) therapy may provide information useful in counseling patients. Objective: To investigate baseline characteristics associated with 6-month VA and central subfield thickness (CST) outcomes in participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2). Design, Setting, and Participants: A total of 362 patients with central RVO or hemi-RVO were enrolled between September 17, 2014, and November 18, 2015, and randomized 1:1 in a masked fashion to receive bevacizumab or aflibercept. At month 6, 348 participants (96%) had VA outcomes measured and 335 participants (93%) had spectral domain optical coherence tomography outcomes measured. The current data analysis was conducted from February 27, 2017, to April 7, 2017. Interventions: Eyes were randomly assigned to receive an intravitreal injection of bevacizumab, 1.25 mg, or aflibercept, 2.0 mg, at baseline and every 4 weeks, with the primary outcome measured at 6 months. Main Outcomes and Measures: Change from baseline in VA letter score (VALS), VALS gain of 15 or more, change from baseline in CST, CST less than 300 µm, and resolution of ME. Baseline factors associated with 6-month outcome at the 0.05 level in univariate regressions were included in multivariate regressions, with those significant after multiplicity control by the Hochberg method reported. Results: The mean (SD) age of patients was 69 (12) years, and 43% were women. Younger patient age (odds ratio [OR], 0.95 per year of age; 95% CI, 0.93-0.98; P = .007) and lower baseline VALS (OR, 0.96 per letter; 95% CI, 0.94-0.98; P < .001) were associated with a 6-month VALS gain of 15 or greater. Compared with bevacizumab, aflibercept treatment was associated with a higher odds of ME resolution (OR, 3.59; 95% CI, 2.22-5.80; P < .001) and CST less than 300 µm (OR, 5.30; 95% CI, 2.40-11.67; P = .001), but not with a better VA outcome. Macular edema was less likely to resolve in eyes that received anti-VEGF treatment prior to study participation (OR, 0.33; 95% CI, 0.17-0.64; P = .03). Conclusions and Relevance: In eyes treated with bevacizumab or aflibercept, younger age and worse baseline VALS were associated with better 6-month VA outcomes. Aflibercept treatment was associated with more favorable spectral domain optical coherence tomography outcomes but not VA outcomes. These findings may be useful in assessing expected response at month 6 after monthly injection of anti-VEGF agents for treating ME due to CRVO and HRVO. Trial Registration: clinicaltrials.gov Identifier: NCT01969708.
Asunto(s)
Bevacizumab/administración & dosificación , Edema Macular/etiología , Receptores de Factores de Crecimiento Endotelial Vascular/administración & dosificación , Proteínas Recombinantes de Fusión/administración & dosificación , Retina/patología , Oclusión de la Vena Retiniana/complicaciones , Agudeza Visual , Anciano , Inhibidores de la Angiogénesis/administración & dosificación , Femenino , Estudios de Seguimiento , Humanos , Inyecciones Intravítreas , Edema Macular/diagnóstico , Edema Macular/fisiopatología , Masculino , Persona de Mediana Edad , Oclusión de la Vena Retiniana/diagnóstico , Oclusión de la Vena Retiniana/tratamiento farmacológico , Estudios Retrospectivos , Factores de Tiempo , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidoresRESUMEN
PURPOSE: To compare rates and identify predictive factors for events that represent worsening of proliferative diabetic retinopathy (PDR) in eyes treated with panretinal photocoagulation (PRP) or ranibizumab. DESIGN: Randomized clinical trial (55 United States sites). PARTICIPANTS: Three hundred ninety-four study eyes from 305 adults with PDR, visual acuity (VA) 20/320 or better, and no history of PRP. INTERVENTION: Panretinal photocoagulation or intravitreous ranibizumab injections (0.5 mg/0.05 ml). MAIN OUTCOME MEASURES: Time from randomization to a composite PDR-worsening outcome defined as the first occurrence of vitreous hemorrhage, retinal detachment, anterior segment neovascularization, or neovascular glaucoma. RESULTS: Through 2 years, the cumulative probability of worsening PDR was 42% (PRP) versus 34% (ranibizumab; hazard ratio [HR], 1.33; 99% confidence interval [CI], 0.90 to 1.98; P = 0.063). Worse baseline levels of diabetic retinopathy severity (Early Treatment Diabetic Retinopathy Study scale) were associated with increased risk of worsening PDR, regardless of treatment group (64% [high-risk PDR or worse] vs. 23% [moderate PDR or better]; HR, 3.97; 99% CI, 2.48 to 6.36; P < 0.001). In the PRP group, eyes receiving pattern scan versus conventional single-spot PRP also were at higher risk for worsening PDR (60% vs. 39%; HR, 2.04; 99% CI, 1.02 to 4.08; P = 0.008), regardless of the number of spots placed or the number of sittings to complete the initial PRP. Eyes in both groups with vision-impairing (VA 20/32 or worse) center-involved diabetic macular edema (DME) at baseline were required to receive ranibizumab for center-involved DME. Therefore the composite outcome was compared by treatment in the subgroup of eyes that did not have vision-impairing center-involved DME at baseline. For these eyes, the rate of PDR-worsening was greater with PRP than ranibizumab (45% vs. 31%; HR, 1.62; 99% CI, 1.01 to 2.60; P = 0.008). CONCLUSIONS: In eyes with PDR, ranibizumab resulted in less PDR worsening compared with PRP, especially in eyes not required to receive ranibizumab for center-involved DME. Although anti-vascular endothelial growth factor therapy requires a more frequent visit schedule than PRP, these findings provide additional evidence supporting the use of ranibizumab as an alternative therapy to PRP for PDR, at least through 2 years.
Asunto(s)
Inhibidores de la Angiogénesis/uso terapéutico , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/terapia , Coagulación con Láser , Ranibizumab/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Segmento Anterior del Ojo/irrigación sanguínea , Retinopatía Diabética/fisiopatología , Progresión de la Enfermedad , Femenino , Glaucoma Neovascular/diagnóstico , Humanos , Inyecciones Intravítreas , Masculino , Persona de Mediana Edad , Neovascularización Patológica/diagnóstico , Modelos de Riesgos Proporcionales , Desprendimiento de Retina/diagnóstico , Factores de Riesgo , Tomografía de Coherencia Óptica , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Agudeza Visual/fisiología , Hemorragia Vítrea/diagnóstico , Adulto JovenRESUMEN
PURPOSE: To evaluate vitrectomy for diabetic macular edema (DME) in eyes with at least moderate vision loss and vitreomacular traction. DESIGN: Prospective cohort study. PARTICIPANTS: The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield >300 microns and no concomitant cataract extraction at the time of vitrectomy. METHODS: Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year. MAIN OUTCOME MEASURES: Visual acuity, OCT retinal thickening, and operative complications. RESULTS: At baseline, median visual acuity in the 87 eyes was 20/100 and median OCT thickness was 491 microns. During vitrectomy, additional procedures included epiretinal membrane peeling in 61%, internal limiting membrane peeling in 54%, panretinal photocoagulation in 40%, and injection of corticosteroids at the close of the procedure in 64%. At 6 months, median OCT central subfield thickness decreased by 160 microns, with 43% having central subfield thickness <250 microns and 68% having at least a 50% reduction in thickening. Visual acuity improved by > or =10 letters in 38% (95% confidence interval, 28%-49%) and deteriorated by > or =10 letters in 22% (95% confidence interval, 13%-31%). Postoperative complications through 6 months included vitreous hemorrhage (5 eyes), elevated intraocular pressure requiring treatment (7 eyes), retinal detachment (3 eyes), and endophthalmitis (1 eye). Few changes in results were noted between 6 months and 1 year. CONCLUSIONS: After vitrectomy performed for DME and vitreomacular traction, retinal thickening was reduced in most eyes. Between 28% and 49% of eyes with characteristics similar to those included in this study are likely to have improvement of visual acuity, whereas between 13% and 31% are likely to have worsening. The operative complication rate is low and similar to what has been reported for this procedure. These data provide estimates of surgical outcomes and serve as a reference for future studies that might consider vitrectomy for DME in eyes with at least moderate vision loss and vitreomacular traction.
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Retinopatía Diabética/cirugía , Oftalmopatías/cirugía , Edema Macular/cirugía , Vitrectomía , Cuerpo Vítreo/cirugía , Anciano , Estudios de Cohortes , Retinopatía Diabética/fisiopatología , Oftalmopatías/fisiopatología , Femenino , Estudios de Seguimiento , Humanos , Edema Macular/fisiopatología , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Estudios Prospectivos , Retina/patología , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Agudeza Visual/fisiologíaRESUMEN
Simulation modeling can be used in aiding decision-makers in deciding when to invest in additional research and when the risky animal disease-import decision should go forward. Simulation modeling to evaluate value-of-information (VOI) techniques provides a robust, objective and transparent framework for assisting decision-makers in making risky animal and animal product decisions. In this analysis, the hypothetical risk from poultry disease in chicken-meat imports was modeled. Economic criteria were used to quantify alternative confidence-increasing decisions regarding potential import testing and additional research requirements. In our hypothetical example, additional information about poultry disease in the exporting country (either by requiring additional export-flock surveillance that results in no sign of disease, or by conducting additional research into lack of disease transmittal through chicken-meat ingestion) captured >75% of the value-of-information attainable regarding the chicken-meat-import decision.