Clinical trial NCT05736081: Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema
Official title: Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Keywords: Diabetic macular edema
Ozurdex
Dexamethasone intravitreal implant
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Change in central retinal thickness
timeFrame: Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI
Secondary outcomes:
measure: Change in Best Corrected Visual Acuity
timeFrame: Prospective: from baseline to 1 month post IDI
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Asociacion Para Evitar la Ceguera en Mexico
state: Coyoacan
Study officials:
affiliation: Asociación para Evitar la Ceguera en México I.A.P.
name: José Gerardo García Aguirre, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
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.