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

July 31, 2024 updated by: Asociación para Evitar la Ceguera en México

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Coyoacan
      • Mexico city, Coyoacan, Mexico, 04030
        • Asociación Para Evitar la Ceguera en México

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravitreal dexamethasone implant
All patients were included here and received one intravitreal dexamethasone implant 0.7mg
Drug: Intravitreal dexamethasone implant
Intravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops
Other Names:
  • Ozurdex implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Prospective: from baseline to 1 month post IDI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Principal Investigator: José Gerardo García Aguirre, MD, Asociación para Evitar la Ceguera en México I.A.P.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RE-20-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

IPD will be available when the summary date are published

IPD Sharing Access Criteria

VIa e-mail with José Gerardo García Aguirre MD, all IPD that underlie results in a publication will be available

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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