Local Safety Concerns of Repited Dexamethasone Intravitreal Implant (Ozurdex®) For Macular Diseases 

Authors

  • Roberto Gallego-Pinazo Department of Ophthalmology, University and Polytechnic Hospital La Fe, Valencia, Spain
  • Pablo q Hernández-Martinez Department of Ophthalmology, University and Polytechnic Hospital La Fe, Valencia, Spain
  • Ana Hervás-Ontiveros Department of Ophthalmology, University and Polytechnic Hospital La Fe, Valencia, Spain
  • Sebastián Martínez-Castillo Department of Ophthalmology, University and Polytechnic Hospital La Fe, Valencia, Spain
  • Rosa Dolz-Marco Department of Ophthalmology, University and Polytechnic Hospital La Fe, Valencia, Spain
  • J. Fernando Arévalo Department of Retina, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA and King Khaled Eye Specialist Hospital, Riyhad, Saudi Arabia
  • Lihteh Wu Instituto de Cirugía Ocular, San José, Costa Rica
  • Manuel Díaz-Llopis Department of Ophthalmology, University and Polytechnic Hospital La Fe, Valencia, Spain and Faculty of Medicine, University of Valencia, Spain

DOI:

https://doi.org/10.12974/2309-6136.2013.01.01.3

Keywords:

Cataract, Dexamethasone Intravitreal Implant, Macular Diseases, Macular Edema, Ocular Hypertension, Ozurdex®, Safety.

Abstract

Introduction: The objective of the present study was to analyze the expanding indications for the dexamethasone intravitreal implant (Ozurdex®) in macular edema of varied diseases, and determine its safety concerns. 

Materials and Methods: We retrospectively reviewed the ophthalmic charts of patients treated with at least one intravitreal injection of Ozurdex® since April 2010 to October 2011. Data regarding complications of the procedure as well as the need for cataract surgery were collected. No patient with the diagnosis of glaucoma was included in the present study. Early recurrences where treated with laser photocoagulation or intravitreal ranibizumab at the discretion of the physician; late recurrences where treated with a new Ozurdex® injection. 

Results: The causative diseases of ME in the 214 eyes of our sample were: diabetic macular edema (101 eyes of 84 patients); branch retinal vein occlusion (27 eyes of 27 patients with superior temporal branch occlusion; 6 eyes of 6 patients with inferior temporal branch occlusion); central retinal vein occlusion (23 eyes of 23 patients); uveitic macular edema (13 eyes of 11 patients). Patients with other indications such as exudative age-related macular degeneration (27 eyes of 27 patients), and pseudophakic cystoid macular edema (7 eyes of 7 patients). Regarding complications, we found a rate of posterior cataract progression in 69.6% of phakic eyes after receiving a second intravitreal Ozurdex® for the treatment of ME. A significant IOP increase was evidenced in 21.18% of cases following the first Ozurdex® implant. Patients with uveitic macular edema (UME) showed the greatest rate of IOP increase (53.86%) following Ozurdex® implant. In addition, anterior chamber migration of the Ozurdex® implant was seen in 2 cases with lens posterior capsule rupture. 

Discussion: This is a descriptive study of 214 eyes of 189 patients treated with intravitreal Ozurdex® in real-life conditions, which adds an important value for the retinal physicians. Further long-term studies are warranted in order to establish a more accurate safety profile of Ozurdex® for retinal diseases. 

References

Antonetti DA, Barber AJ, Khin S, Lieth E, Tarbell JM, Gardner TW. Vascular permeability in experimental diabetes is associated with reduced endothelial occludin content: vascular endothelial growth factor decreases occludin in retinal endothelial cells. Penn State Retina Research Group. Diabetes 1998; 47: 1953-9. http://dx.doi.org/10.2337/diabetes.47.12.1953

Campochiaro PA, Hafiz G, Shah SM, Nguyen QD, Ying H, Do DV, et al. Ranibizumab for macular edema due to retinal vein occlusions: implication of VEGF as a critical stimulator. Mol Ther 2008; 16: 791-9. http://dx.doi.org/10.1038/mt.2008.10

Funatsu H, Yamashita H, Noma H, Mimura T, Yamashita T, Hori S. Increased levels of vascular endothelial growth factor and interleukin-6 in the aqueous humor of diabetics with macular edema. Am J Ophthalmol 2002; 133: 70-7. http://dx.doi.org/10.1016/S0002-9394(01)01269-7

Arevalo JF, Maia M, Garcia-Amaris RA, Roca JA, Sanchez JG, Berrocal MH, et al. Pan-American Collaborative Retina Study Group. Intravitreal bevacizumab for refractory pseudophakic cystoid macular edema: the Pan-American Collaborative Retina Study Group results. Ophthalmology 2009; 116: 1481-7, 1487.e1.

Patel JI, Tombran-Tink J, Hykin PG, Gregor ZJ, Cree IA. Vitreous and aqueous concentrations of proangiogenic, antiangiogenic factors and other cytokines in diabetic retinopathy patients with macular edema: Implications for structural differences in macular profiles. Exp Eye Res 2006; 82: 798-806. http://dx.doi.org/10.1016/j.exer.2005.10.002

Ferris FL 3rd, Patz A. Macular edema. A complication of diabetic retinopathy. Surv Ophthalmol 1984; 28(Suppl): 452- 61. http://dx.doi.org/10.1016/0039-6257(84)90227-3

Orth DH, Patz A. Retinal branch vein occlusion. Surv Ophthalmol 1978; 22: 357-76. http://dx.doi.org/10.1016/0039-6257(78)90132-7

Durrani OM, Tehrani NN, Marr JE, Moradi P, Stavrou P, Murray PI. Degree, duration, and causes of visual loss in uveitis. Br J Ophthalmol 2004; 88: 1159-62. http://dx.doi.org/10.1136/bjo.2003.037226

Kim SJ, Belair ML, Bressler NM, Dunn JP, Thorne JE, Kedhar SR, Jabs DA. A method of reporting macular edema after cataract surgery using optical coherence tomography. Retina 2008; 28: 870-6. http://dx.doi.org/10.1097/IAE.0b013e318169d04e

Kuppermann BD, Blumenkranz MS, Haller JA, Williams GA, Weinberg DV, Chou C, et al. Dexamethasone DDS Phase II Study Group. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Ophthalmol 2007; 125: 309-17. http://dx.doi.org/10.1001/archopht.125.3.309

Cantrill HL, Waltman SR, Palmberg PF, Zink HA, Becker B. In vitro determination of relative corticosteroid potency. J Clin Endocrinol Metab 1975; 40: 1073-7. http://dx.doi.org/10.1210/jcem-40-6-1073

West KM, Johnson PC, Kyriakopoulos AA, Bahr WJ, Bloedow CE. The physiologic effects of dexamethasone. Arthritis Rheum 1960; 3: 129-39. http://dx.doi.org/10.1002/art.1780030204

London NJ, Chiang A, Haller JA. The dexamethasone drug delivery system: indications and evidence. Adv Ther 2011; 28(5): 351-66. http://dx.doi.org/10.1007/s12325-011-0019-z

Gallego-Pinazo R, Marín-Lambíes C, Marín-Olmos F, Martínez R, Fons R, Díaz-Llopis M. Intravitreal dexamethasone as an enhancer for the anti-VEGF treatment in neovascular ARMD: recovering an old ally. Arch Soc Esp Oftalmol 2010; 85(2): 79-80.

Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, et al. OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology 2010; 117(6): 1134- 1146.e3.

Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, et al. Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol 2011; 129(5): 545-53. http://dx.doi.org/10.1001/archophthalmol.2010.339

Pardo-López D, Francés-Muñoz E, Gallego-Pinazo R, Díaz- Llopis M. Anterior chamber migration of dexametasone intravitreal implant (Ozurdex®). Graefes Arch Clin Exp Ophthalmol 2011; (PMID: 21861084).

Bansal R, Bansal P, Kulkarni P, Gupta V, Sharma A, Gupta A. Wandering Ozurdex(®) implant. J Ophthalmic Inflamm Infect 2012. http://dx.doi.org/10.1007/s12348-011-0042-x

Downloads

Published

2013-04-04

How to Cite

Gallego-Pinazo, R. ., Hernández-Martinez, P. q, Hervás-Ontiveros, A. ., Martínez-Castillo, S. ., Dolz-Marco, R. ., Arévalo, J. F., Wu, L., & Díaz-Llopis, M. . (2013). Local Safety Concerns of Repited Dexamethasone Intravitreal Implant (Ozurdex®) For Macular Diseases . Journal of Ocular Diseases and Therapeutics, 1(1), 10–14. https://doi.org/10.12974/2309-6136.2013.01.01.3

Issue

Section

Articles