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

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.

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Key information

Conditions

Diabetic Macular Edema

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asociacion Para Evitar la Ceguera en Mexico

Mexico City, Coyoacan, 04030, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreal dexamethasone implant

Drug

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

Other names: Ozurdex implant

Primary outcomes

Change in central retinal thickness

Time frame: 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 outcomes

Change in Best Corrected Visual Acuity

Time frame: Prospective: from baseline to 1 month post IDI

Measurement of Best Corrected Visual Acuity before and after IDI

Sponsors and collaborators

Lead sponsor

Asociación para Evitar la Ceguera en México

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Feb 21, 2023
Registry last updated: Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed