Guías de práctica clínica de la SERV: Tratamiento de la degeneración macular asociada a la edad (DMAE) exudativa

Abstract

RESUMENObjetivo: La Degeneración Macular Asociada a la Edad (DMAE) en su forma húmeda supone una grave enfermedad que condiciona ceguera legal en muchos pacientes y con mal pronóstico si no es tratada. Pretendemos establecer una guía de actuación clínica con las diferentes opciones terapeúticas que existen en el momento actual, que puedan ayudar al oftalmólogo en su práctica clínica. Métodos: Un grupo de expertos en retina médica seleccionados por la SERV han evaluado los resultados de los diferentes estudios publicados con los fármacos actualmente disponibles, llegando a un ABSTRACT Objective: Age related macular degeneration (ARMD) in its neovascular form is a serious disease which produces legal blindness in many patients with poor prognosis if left untreated. We intend to establish a clinical guide with the different therapeutic options that exist nowadays, which may help the ophthalmologists in their clinical practice. Methods: A group of medical retina experts selected by SERV have evaluated the results of different published studies with the drugs currently available, obtaining an evidence-based consensus. Some recommendations have been established for diagno-

Age-Related Macular Degeneration: Clinical Findings following Treatment with Antiangiogenic Drugs

“…Likewise, the Lumiere study reflected poor compliance with treatment recommendations in France [11]. For example, the SERV Guideline and three German ophthalmologic societies recommend a loading treatment initiation followed by monthly follow-up visits to detect early recurrences and perform prompt retreatments to avoid as much as possible the permanent anatomic and functional damage [9, 10]. …”

“…The Phase III MARINA and ANCHOR trials with ranibizumab were designed with fixed monthly injections over a period of two years [7, 8]. However, as this treatment strategy is difficult to undertake in the regular clinical practice, other alternative approaches have been proposed by some retina specialist societies from several European countries, like the Spanish Society of Retina and Vitreous (SERV), recommending an initial loading dose followed by maintenance injections on an as-needed basis (PRN: per re nata ) according to visual acuity and optical coherence tomography (OCT) changes [9]. Likewise, three German ophthalmologic societies [10] (der Retinologischen Gesellschaft, der Deutschen Ophthalmologischen Gesellschaft und des Berufsverbands der Augenärzte Deutschlands e.V.)…”

“…and the prescription guidelines in France [11] recommend an initial 3-month upload phase of monthly injections and retreatment to prevent disease progression if there is evidence of disease activity or vision deterioration. Monitoring visits are recommended at monthly intervals following the upload phase in Germany [10] and in Spain [9]. Although some recent clinical practice studies have assessed the compliance with these guidelines [11–15], nothing has been published regarding the Spanish situation.…”

Funduscopic results after 4-year follow-up treatment with ranibizumab for age-related macular degeneration in a region of Spain

“…Patients included had treatment-naive exudative AMD and started treatment between January 1, 2008, and December 31, 2010, with intravitreal ranibizumab following the Spanish Society of Retina and Vitreous protocol treatment [ 4 ]. Spanish and European guidelines recommended at that time a loading dose consisting of three initial consecutive monthly injections and thereafter an as needed treatment, also known as pro re nata (PRN), where injections are administered when visual acuity loss and signs of lesion activity occur [ 13 , 14 ].…”

“…In pivotal clinical trials, ranibizumab was administered every month for 2 years and good functional results were obtained. However, subsequent studies theorized that a judiciously administered course of variable-frequency pro re nata intravitreal ranibizumab treatment preserves vision in three quarters of patients and improves vision in one third becoming the accepted protocol [ 3 , 4 ]. Several authors have reported clinical practice outcomes and adherence to this treatment regime in different European countries [ 5 – 7 ], but only one study presented results beyond 1 year of follow-up [ 8 ].…”