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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05736081
Other study ID # RE-20-13
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date February 15, 2018
Est. completion date June 30, 2019

Study information

Verified date February 2023
Source Asociación para Evitar la Ceguera en México
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intravitreal dexamethasone implant
Intravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops

Locations

Country Name City State
Mexico Asociacion Para Evitar la Ceguera en Mexico Mexico city Coyoacan

Sponsors (1)

Lead Sponsor Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

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

Outcome

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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