Recommendations for the use of ranibizumab in diabetic macular edema at IMSS
Main Article Content
Keywords
Diabetic retinopathy, Macular edema, Ranibizumab
Abstract
Diabetic macular edema can occur at any stage of diabetic retinopathy. It represents the main cause of vision loss in diabetes type I and II with a prevalence of 3-10% in diabetic patients of the Instituto Mexicano del Seguro Social (IMSS). Our aim is to elaborate treatment guidelines and provide recommendations for the use of intravitreal ranibizumab for diabetic medical edema at IMSS. Nine retina specialists and 10 ophthalmologists from IMSS high specialty medical units gathered to discuss the bibliographic evidence for the safety and efficacy of ranibizumab for this disease, in order to create consensus on its use in the institution. Intravitreal ranibizumab injection should be used on patients presenting diffuse or cystic diabetic macular edema who have strict metabolic control and visual acuity between 20/30 and 20/200 ETDRS, as well as structural features, such as inferior foveal limit of 280 μm and ischemic areas no larger than 50% of the central foveal area. Treatment regime should consist of a loading charge of three monthly injections of ranibizumab 0.5 mg, followed by monthly follow-ups and treatment as needed according to anatomic and functional criteria. This consensus decision-making process on the criteria to treat and re-treat patients with this drug will result in better health outcomes than those currently observed among patients with diabetic macular edema at IMSS.
References
Hernández-Ávila M, Gutiérrez JP, Reynoso-Noverón N. Diabetes mellitus en México. El estado de la epidemia. Salud Publica Mex. 2013;55(2):s129-36.
Gil-Velázquez LE, Sil-Acosta MJ, Aguilar-Sánchez L, Echevarría-Zuno S, Michaus-Romero F, Torres-Arreola LP. Perspectiva de la diabetes Mellitus tipo 2 en el Instituto Mexicano del Seguro Social. Rev Med Inst Mex Seguro Soc. 2013;51(1):58-67.
Rodriguez-Villalobos E, Cervantes Aguayo F, Vargas-Salado E, Ávalos-Muñoz MA, Juárez-Becerril DM, Ramírez-Barba EJ. Retinopatía diabética. Incidencia y progresión a 12 años. Cir Ciruj. 2005;73:79-84.
Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of diabetic retinopathy. XIV. Ten-year incidence and progression of diabetic retinopathy. Arch Ophthalmol 1994;112:1217-28.
Cunha-Vaz JG. Pathophysiology of diabetic retinopathy. Br J Ophthalmol. 1978 Jun; 62(6): 351-5.
Clarke PM, Simon J, Cull CA, Holman RR. Assessing the Impact of Visual Acuity on Quality of Life in Individuals With Type 2 Diabetes Using the Short Form-36. Diabetes Care. 2006;29(7):1506-11.
Aiello LP; the DCCT/EDIC Research Group. Diabetic Retinopathy and Other Ocular Findings in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study. Diabetes Care. 2014;37(1):17-23.
Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. Glycosylated hemoglobin predicts the incidence and progression of diabetic retinopathy. JAMA. 1988 Nov 18;260(19):2864-71.
Wong-Riley MT. Energy metabolism of the visual system. Eye Brain. 2010;2:99-116.
Oshitari T, Hata N, Yamamoto S. Endoplasmic reticulum stress and diabetic retinopathy. Vasc Health Risk Manag. 2008 Feb;4(1):115-22.
Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005;115:1111-20.
Kowluru RA, Chan P-S. Oxidative stress and diabetic retinopathy. Exp Diabetes Res. 2007;2007:43603. doi:10.1155/2007/43603
Kern TS. Contributions of inflammatory processes to the development of the early stages of diabetic retinopathy. Exp Diabetes Res. 2007;2007:95103. doi: 10.1155/2007/95103.
Das A, McGuire PG, Rangasamy S. Diabetic Macular Edema: Pathophysiology and Novel Therapeutic Targets. Ophthalmology. 2015 Jul;122(7):1375-94.
Secretaría de Salud/Centro Nacional de Excelencia Tecnológica en Salud. Guía Práctica Clínica. Diagnóstico y Tratamiento de Edema Macular Diabético en el Segundo Nivel de Atención. México: Secretaría de Salud; 2015.
Early Treatment Diabetic Retinopathy Study research group. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol. 1985;103:1796-806.
Nguyen QD, Tatlipinar S, Shah SM, Haller JA, Quinlan E, Sung J, et al. Vascular Endothelial Growth Factor Is a Critical Stimulus for Diabetic Macular Edema. Am J Ophthalmol. 2006;142(6):961-9.
Massin P, Bandello F, Garweg JG, Hansen LL, Harding SP, Larsen M, et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care. 2010;33(11):2399-405.
Nguyen QD, Shah SM, Khwaja AA, Channa R, Hatef E, Do DV, et al. Two-year outcomes of the ranibizumab for edema of the macula in diabetes (READ-2) study. Ophthalmology. 2010 Nov;117(11):2146-51.
Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011;118(4):615-25.
Nguyen QD, Brown DM, Marcus DM, Boyer DS, Patel S, Feiner L, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012;119 (4):789-801.
Diabetic Retinopathy Clinical Research Network, Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, et al. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010;117(6):1064-77.
American Academy of Ophthalmology Retina/Vitreous Panel. Preferred Practice Pattern Guidelines. Diabetic Retinopathy. American Academy of Ophthalmology; 2016.
Lovestam-Adrian M, Agardh E, Agardh CD. The temporal development of retinopathy and nephropathy in type 1 diabetes mellitus during 15 years diabetes duration. Diabetes Res Clin Pract. 1999;45:15-23.
[No authors listed]. Grading diabetic retinopathy from stereoscopic color fundus photographs--an extension of the modified Airlie House classification. ETDRS report number 10. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):786-806.
Wilkinson CP, Ferris FL, Klein RE, Lee PP, Agardh CD, Davis M. Proposed international clinical diabetic retinopathy and diabetic macular edema disease severity scales. Ophthalmology. 2003 Sep;110(9): 1677-82.
[No authors listed]. Classification of diabetic retinopathy from fluorescein angiograms. ETDRS report number 11. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):807-22.
Secretaría de Salud. Detección de retinopatía diabética en el primer nivel de atención. México: Secretaría de Salud; 11 de diciembre de 2014.
Prunte C, Fajnkuchen F, Mahmood S, Ricci F, Hatz K, Studnicka J, et al. Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study. Br J Ophthalmol. 2016 Jun;100(6): 787-95.
American Academy of Ophthalmology. General Guidelines for administering intravitreal injections. American Academy of Ophthalmology; 2016.