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

Phase 4

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Intravitreal dexamethasone implant

• Registration Number: NCT05736081
• Lead Sponsor: Asociación para Evitar la Ceguera en México

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

Study Timeline

• Study Start: 2018-02-15
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravitreal dexamethasone implant	Intravitreal dexamethasone implant	All patients were included here and received one intravitreal dexamethasone implant 0.7mg

Primary Outcome Measures

Name	Time	Method
Change in central retinal thickness	Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI	Difference among the baseline and the posterior measurements of the CRT with OCT

Secondary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity	Prospective: from baseline to 1 month post IDI	Measurement of Best Corrected Visual Acuity before and after IDI

Trial Locations

Locations (1)

Asociacion Para Evitar la Ceguera en Mexico; 🇲🇽 Mexico city, Coyoacan, Mexico