Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intravitreal dexamethasone implant All patients were included here and received one intravitreal dexamethasone implant 0.7mg |
Procedure: Intravitreal dexamethasone implant
Intravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in central retinal thickness [Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI]
Difference among the baseline and the posterior measurements of the CRT with OCT
Secondary Outcome Measures
- Change in Best Corrected Visual Acuity [Prospective: from baseline to 1 month post IDI]
Measurement of Best Corrected Visual Acuity before and after IDI
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asociacion Para Evitar la Ceguera en Mexico | Mexico city | Coyoacan | Mexico | 04030 |
Sponsors and Collaborators
- Asociación para Evitar la Ceguera en México
Investigators
- Principal Investigator: José Gerardo García Aguirre, MD, Asociación para Evitar la Ceguera en México I.A.P.
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- RE-20-13