Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

Summary

The goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (IDI) in patients with refractory diabetic macular edema. The main question it aims to answer is: How fast does the diminishing in central retinal thickness has statistical significance after IDI in patients with refractory diabetic macular edema? Patients will be evaluated by OCT before and after the implant.

Timeline

Start

2018-02-15

Primary completion

2019-06-30

Completion

2019-06-30

Publications

• Background Tang J, Kern TS. Inflammation in diabetic retinopathy. Prog Retin Eye Res. 2011 Sep;30(5):343-58. doi: 10.1016/j.preteyeres.2011.05.002. Epub 2011 May 25.
• Background Noma H, Yasuda K, Shimura M. Involvement of Cytokines in the Pathogenesis of Diabetic Macular Edema. Int J Mol Sci. 2021 Mar 26;22(7):3427. doi: 10.3390/ijms22073427.
• Background Wallsh JO, Gallemore RP. Anti-VEGF-Resistant Retinal Diseases: A Review of the Latest Treatment Options. Cells. 2021 Apr 29;10(5):1049. doi: 10.3390/cells10051049.
• Background Bressler SB, Ayala AR, Bressler NM, Melia M, Qin H, Ferris FL 3rd, Flaxel CJ, Friedman SM, Glassman AR, Jampol LM, Rauser ME; Diabetic Retinopathy Clinical Research Network. Persistent Macular Thickening After Ranibizumab Treatment for Diabetic Macular Edema With Vision Impairment. JAMA Ophthalmol. 2016 Mar;134(3):278-85. doi: 10.1001/jamaophthalmol.2015.5346.
• Background Boyer DS, Yoon YH, Belfort R Jr, Bandello F, Maturi RK, Augustin AJ, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014 Oct;121(10):1904-14. doi: 10.1016/j.ophtha.2014.04.024. Epub 2014 Jun 4.
• Background Khan Z, Kuriakose RK, Khan M, Chin EK, Almeida DR. Efficacy of the Intravitreal Sustained-Release Dexamethasone Implant for Diabetic Macular Edema Refractory to Anti-Vascular Endothelial Growth Factor Therapy: Meta-Analysis and Clinical Implications. Ophthalmic Surg Lasers Imaging Retina. 2017 Feb 1;48(2):160-166. doi: 10.3928/23258160-20170130-10.
• Moreno JB, Medina DB, Rosellon-Escobar MF, Garcia-Aguirre JG. Short-term effect of intravitreal dexamethasone implant in refractory diabetic macular edema. BMC Ophthalmol. 2024 Mar 11;24(1):113. doi: 10.1186/s12886-024-03341-9.

Drugs

Indications