Diabetic Macular Edema Clinical Trial
Official title:
Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema
Verified date | February 2023 |
Source | Asociación para Evitar la Ceguera en México |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - patients with type 1 or type 2 diabetes - diabetic macular edema involving the foveal center with CRT >300 µm measured by OCT - at least 3 and maximum 9 monthly intravitreal injections of anti-VEGF Exclusion Criteria: - uncontrolled diabetes (blood glucose = 250 mg/dL at any time - previous IDI - any condition precluding adequate fundus visualization - uncontrolled glaucoma - papillary excavation = 0.7 |
Country | Name | City | State |
---|---|---|---|
Mexico | Asociacion Para Evitar la Ceguera en Mexico | Mexico city | Coyoacan |
Lead Sponsor | Collaborator |
---|---|
Asociación para Evitar la Ceguera en México |
Mexico,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in central retinal thickness | Difference among the baseline and the posterior measurements of the CRT with OCT | Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI | |
Secondary | Change in Best Corrected Visual Acuity | Measurement of Best Corrected Visual Acuity before and after IDI | Prospective: from baseline to 1 month post IDI |
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