Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05736081
• Other study ID #: RE-20-13
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

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