Ceguera digna y degeneración macular asociada a la edad. Un necesario enfoque multidisciplinar / Dignified blindness and age-related macular degeneration. A necessary multidisciplinary approach

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A longitudinal study to assess the frequency and cost of antivascular endothelial therapy, and inequalities in access, in England between 2005 and 2015.

OBJECTIVES: High-cost antivascular endothelial growth factor (anti-VEGF) medicines for eye disorders challenge ophthalmologists and policymakers to provide fair access for patients while minimising costs. We describe the growth in the use and costs of these medicines and measure inequalities in access. DESIGN: Longitudinal study using Hospital Episode Statistics (2005/2006 to 2014/2015) and hospital prescribing cost reports (2008/2009 to 2015/2016). We used Poisson regression to estimate standardised rates and explore temporal and geographical variations. SETTING: National Health Service (NHS) care in England. POPULATION: Patients receiving anti-VEGF injections for age-related macular degeneration, diabetic macular oedema and other eye disorders. INTERVENTIONS: Higher-cost drugs (ranibizumab or aflibercept) recommended by the National Institute for Health and Care Excellence or lower-cost drug (bevacizumab) not licensed for eye disorders. MAIN OUTCOME MEASURES: National procedure rates and variation between and within clinical commissioning groups (CCGs). Cost of ranibizumab and aflibercept prescribing. RESULTS: Injection procedures increased by 215% between 2010/2011 and 2014/2015. In 2014/2015 there were 388 031 procedures (714 per 100 000). There is no evidence that the dramatic growth in rates is slowing down. Since 2010/2011 the estimated cost of ranibizumab and aflibercept increased by 247% to £447 million in 2015/2016, equivalent to the entire annual budget of a CCG. There are large inequalities in access; in 2014/2015 procedure rates in a 'high use' CCG were 9.08 times higher than in a 'low use' CCG. In the South-West of England there was twofold variation in injections per patient per year (range 2.9 to 5.9). CONCLUSIONS: The high and rising cost of anti-VEGF therapy affects the ability of the NHS to provide care for other patients. Current regulations encourage the increasing use of ranibizumab and aflibercept rather than bevacizumab, which evidence suggests is more cost-effective. NHS patients in England do not have equal access to the most cost-effective care.

Pharmacokinetic and Pharmacodynamic Properties of Anti-VEGF Drugs After Intravitreal Injection.

Subretinal neovascularization and pathologic ocular angiogenesis are common causes of progressive, irreversible impairment of central vision, and dramatically affect quality of life. Anti-vascular endothelial growth factor (anti-VEGF) therapy has improved the quality of life for many patients with age-related macular degeneration, diabetic retinopathy, and other ocular diseases involving neovascularization and edema. In these pathologies, the inhibition of intraocular VEGF is the only therapy that can preserve vision. Four anti-VEGF drugs are currently used to treat ocular neovascularization; pegaptanib, ranibizumab, and aflibercept have been approved for this condition, while bevacizumab can be used off-label. Anti-VEGF therapy is administered regularly for many months or years because its suspension or discontinuation may cause recurrence of neovascularization. On the other hand, VEGF is necessary for the survival of retinal and choroidal endothelial cells. Experimental studies in animal models have shown that local inhibition of VEGF causes thinning and atrophy of the choriocapillaris and degeneration of photoreceptors, primarily cones. These studies combined with clinical experience indicated that prolonged VEGF inhibition could impair retinal function. Moreover, anti-VEGF compounds can cross the blood-retina barrier, enter the systemic circulation, and inhibit serum VEGF. Since circulating VEGF protects blood vessel integrity, prolonged anti-VEGF treatment could induce thromboembolic adverse events from vascular causes such as heart attack and stroke, and even death. The ocular dosing regimen and systemic toxicity of anti-VEGF compounds are therefore central concerns. A better understanding of this topic requires knowledge of the metabolism, tissue distribution, and clearance of anti-VEGF compounds. This manuscript reviews the properties of anti-VEGF compounds following intravitreal administration.

Evaluación de los cambios en la presión intraocular luego de inyección intravítrea de antiangiogénicos / Evaluation of intraocular pressure changes after intravitreal injections of antiangiogenics

Objetivo: determinar la magnitud de la variación en los valores de la presión intraocular (PIO) luego de la inyección intravítrea de antiangiogénicos. Diseño: serie de casos, observacional, cohorte prospectivo. Participantes: 90 ojos intervenidos de inyección intravítrea de antiangiogénicos. Métodos: a todos los pacientes se les administró bevacizumab o ranibizumab vía intravítrea como tratamiento para su patología subyacente. Se les hicieron controles de presión intraocular a los días 1, 8, 15 y 30 posterior a la inyección. El análisis de la descripción de las variables se realizó a través de medidas de tendencia central y calculo de tablas de frecuencia y gráficas. Para los análisis estadísticos se usó el programa Epi-info 3.5.1 de 2008 y SPSS versión 18 tomando como un valor significativo de los fenómenos una p<0.05. Resultados: La media de edad de los pacientes intervenidos fue de 67.27 años. 71 pacientes (79%) no tenían diagnóstico previo de glaucoma. Los valores de presión intraocular tendieron a la disminución de manera significativa (p<0.05) en todos los controles observándose una regresión a valores cercanos a la presión intraocular previa a la inyección hacia el día 30 post intervención. El comportamiento no varió independiente del tipo de antiangiogénico utilizado, el número de dosis empleada o el hecho de tener o no glaucoma previo. Conclusiones: la inyección de antiangiogénicos intravítreos parece ser segura en cuanto a las modificaciones que induce de la presión intraocular a corto y mediano plazo.

Purpose: to determine the quantity of variation in the values of Intraocular Pressure (IOP) after intravitreal injection of anti-VEGF agents. Design: case series, observational, prospective cohort. Participants: 90 eyes that underwent intravitreal injection of an anti-VEGF agent. Methods: all patients underwent intravitreal injection of Bevacizumab or Ranibizumab as treatment of their subsequent pathology. IOP was then measured at days 1, 8, 15 and 30 after the injection. Descriptive analyses with Epi-info 3.5.1 (2008) and SPSS (18) software was done. Results: mean age of the patients was 67.27 years old. 71 patients (79%) did not have previous glaucoma diagnosis. Th e IOP values tended to decrease in a signifi cant manner (p<0.05) in all the IOP control measures and a regression near to the prior to therapy IOP value was seen at the 30th day post injection. This behavior did not vary according to the type of anti-VEGF used, or the number of doses previously received, neither the previous diagnosis of glaucoma. Conclusions: intravitreal anti-VEGF injections are apparently safe related to the changes in IOP values they induce in the short and medium term.

Nuevas pautas de tratamiento y seguimiento en pacientes con degeneración macular asociada a la edad exudativa / New treatment protocols and follow-up in patients with exudative age-related macular degeneration

Las inyecciones intravítreas de ranibizumab (Lucentis®) son el tratamiento de elección de los pacientes con degeneración macular exudativa. En los últimos años se han ensayado diversas pautas de tratamiento y seguimiento con el fin de optimizar los resultados de eficacia y seguridad. En la práctica clínica habitual, fundamentalmente se utilizan los protocolos PRN (pro re nata) y treat and extend o variantes tipo el régimen FUSION. Los protocolos PRN se basan en el seguimiento regular del paciente y en su retratamiento ante la evidencia de reactivación de la lesión, básicamente determinada por pérdida de agudeza visual y fluido macular persistente o recurrente en la tomografía de coherencia óptica. Los protocolos treat and extend o FUSION se basan en el retratamiento precoz de la lesión antes de que se produzca su reactivación, buscando evitar las pérdidas no reversibles de visión que pueden producirse en las recurrencias de la enfermedad. No se ha podido encontrar un protocolo de tratamiento y seguimiento ideal alternativo al régimen mensual que pueda aplicarse y reproducirse en todos los casos, por lo que el tratamiento con ranibizumab intravítreo debe individualizarse en cada paciente(AU)

Intravitreal ranibizumab (Lucentis®) injections are the treatment of choice in patients with exudative macular degeneration. In the last few years, several treatment and follow-up strategies have been evaluated with the aim of optimizing the safety and efficacy of this drug. In routine clinical practice, the Pro Re Nat a (PRN) and treat-and-extend protocols or variants of the FUSION regimen have been used. PRN protocols are based on regular patient follow-up and on retreatment when there is evidence of reactivation of the lesion, basically determined by loss of visual acuity and persistent or recurrent macular fluid on optical coherence tomography. Treat-and-extend or FUSION protocols are based on early retreatment of the lesion before reactivation occurs with the aim of avoiding the irreversible visual loss that can occur in disease recurrences. There is no ideal treatment and follow-up protocol that could be used as an alternative to the monthly regimen and be applied and reproduced in all patients. Consequently, intravitreal ranibizumab therapy should be individualized in each patient(AU)

Trends over time and geographical variation in rates of intravitreal injections in England.

AIMS: The recent emergence of antivascular endothelial growth factor (anti-VEGF) drugs has led to increased numbers of patients undergoing intravitreal injection for age-related macular degeneration (AMD). The aims of this study were to report on trends over time and geographical variation in intravitreal injection rates in England, and consider the implications for publicly funded health services of introducing new and expensive treatments. METHODS: Hospital episode statistics were analysed for annual treatment rates of intravitreal injection between the NHS financial years of 1989/1990 and 2008/1999. RESULTS: Annual injection rates increased from 0.4 episodes (95% CI 0.37 to 0.49) per 100,000 population in 1989/1990 to 10.7 (10.4-11.0) in 2006/2007. Rates then rose exponentially to 59.5 (58.8-60.2) in 2008/2009, with increasing use of multiple injections per person. The largest growth in injection rates was found in older people, and for AMD. Numbers of treatment episodes increased from 203 (1989/1990) to 30,458 (2008/2009). Geographical analysis showed a very wide variation across local authority areas in injection rates, from 0.9 (0.2-2.2) to 42.2 (38.9-45.7) people per 100,000 population in 2005-2008. CONCLUSION: Rates of intravitreal injection increased exponentially from 2006/2007. This followed the US Food and Drug Association licensing of ranibizumab for the treatment of neovascular AMD (2006), and its recommendation by National Institute for Health and Clinical Excellence (2008). This study demonstrates some of the major issues which arise with the emergence of expensive new treatments, including speed and cost of adoption, geographical variation in access, and implications for licensing, commissioning and health financing in an ageing society.

Coriorretinopatía serosa central recidivante y crónica. Estudio del espesor retiniano al mes del tratamiento con una inyección de bevacizumab intravítreo / Recurrent and chronic central serous chorioretinopathy. Retina thickness evaluation one month after intravitreal bevacizumab injection

Propósito: Evaluar la eficacia de la inyección intravítrea de bevacizumab en pacientes diagnosticados de coriorretinopatía serosa central crónica. Método: Estudio de ocho pacientes con corioretinopatía serosa central tratada con inyección intravitrea de bevacizumab. Se incluye la agudeza visual con la escala de Snellen y el grosor de la mácula, ambas pre- y post-inyección. Resultados: La edad media de los pacientes fue de 50,25 años. El estudio se evaluó al cabo de un mes de evolución. La agudeza visual previa media fue de 0,431±0,249 líneas de visión y la posterior a la inyección fue de 0,631±0,310 líneas de visión (P=0,017). El grosor medio de la mácula fue de 351,25±78,492 μm y post-tratamiento de 183,50±22,640 μm (P=0,012).Conclusión: El bevacizumab intravítreo puede ser una alternativa en los pacientes con coriorretinopatía serosa central ya que existe una mejoría objetiva tanto de la agudeza visual como del grosor macular objetivado con tomografía de coherencia óptica(AU)

Purpose: To evaluate the efficacy of intavitreal injection of bevacizumab in patients with chronic central serous chorioretinopathy. Methods: A study of 8 patients with central serous chorioretinopathy who were treated with intravitreal injection of bevacizumab. We studied the visual acuity with Snellenis method and the foveal thickness, before and after the injection. Results: The mean age of the patients was 50.25 years. After one month of follow-up, visual acuity before the injection was 0.431±0.249 vision lines and after was 0.631±0.310 vision lines (P=.017).The foveal thickness was 351.25±78.492μm and after treatment was 183.50±22.640μm (P=.012). Conclusions: Intravitreal bevacizumab can be an alternative treatment in patients with serous central chorioretinopathy as it leads to a better objective visual acuity and foveal thickness with optical coherence tomography(AU)