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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.
Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal dexamethasone implant | Experimental | All patients were included here and received one intravitreal dexamethasone implant 0.7mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal dexamethasone implant | Drug | Intravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Gerardo GarcÃa Aguirre, MD | Asociación para Evitar la Ceguera en México I.A.P. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociacion Para Evitar la Ceguera en Mexico | Mexico City | Coyoacan | 04030 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21635964 | 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. | |
| 33810434 | 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. |
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All IPD that underlie results in a publication
IPD will be available when the summary date are published
VIa e-mail with José Gerardo GarcÃa Aguirre MD, all IPD that underlie results in a publication will be available
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 8, 2025 | Oct 22, 2025 | 3 |
| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| 33946803 | 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. |
| 26746868 | 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. |
| 24907062 | 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. |
| 28195619 | 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. |
| 38462613 | Derived | 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. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |