Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema
NCT ID: NCT05736081
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
15 participants
INTERVENTIONAL
2018-02-15
2019-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intravitreal dexamethasone implant
All patients were included here and received one intravitreal dexamethasone implant 0.7mg
Intravitreal dexamethasone implant
Intravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops
Interventions
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Intravitreal dexamethasone implant
Intravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* previous IDI
* any condition precluding adequate fundus visualization
* uncontrolled glaucoma
* papillary excavation ≥ 0.7
ALL
No
Sponsors
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Asociación para Evitar la Ceguera en México
OTHER
Responsible Party
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Principal Investigators
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José Gerardo García Aguirre, MD
Role: PRINCIPAL_INVESTIGATOR
Asociación para Evitar la Ceguera en México I.A.P.
Locations
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Asociacion Para Evitar la Ceguera en Mexico
Mexico City, Coyoacan, Mexico
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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RE-20-13
Identifier Type: -
Identifier Source: org_study_id
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