Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

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

The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

A non-randomized prospective clinical interventional study which includes 45 non previously treated patients with DME. The patients received a single intravitreal injection of 2.5 mg bevacizumab. Follow-up included clinical examination (best corrected visual acuity (BCVA, intraocular pressure (IOP), cataract grading, DME characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. OCT and fluorescein angiography was evaluated at months 1 and 3.

Study Type

Interventional

Phase

  • Phase 3

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
    • Distrito Federal
      • Mexico city, Distrito Federal, 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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Macular edema involving the center of the macula demonstrated on OCT
  • Clear ocular media
  • Untreated patients
  • Older than 45 years
  • BCVA of the fellow eye at least 20/100

Exclusion Criteria:

  • Renal diabetic disease, uncontrolled hypertension or stroke history
  • Other ocular disease
  • Ocular surgery excepting uncomplicated phacoemulsification
  • History of photocoagulation (panretinal or focal)
  • History of another intravitreal treatment (like triamcinolone)

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
BCVA
Optical Coherence Tomography
Fluorescein Angiography

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: Adriana Solís-Vivanco, MD, Asociación Para Evitar la Ceguera en México
  • Study Chair: Jans Fromow-Guerra, MD PhD, Asociación Para Evitar la Ceguera en México
  • Study Chair: Myriam Hernández-Rojas, MD, Asociación Para Evitar la Ceguera en México
  • Study Chair: Griselda Alvarez-Rivera, MD, Asociación Para Evitar la Ceguera en México
  • Study Director: Hugo Quiroz-Mercado, MD, Asociación Para Evitar la Ceguera en México
  • Study Chair: Elizabeth Reyna-Castelán, Asociación Para Evitar la Ceguera en México
  • Study Chair: Juan M Jiménez-Sierra, MD, Asociación Para Evitar la Ceguera en México

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)

September 1, 2005

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimated)

January 4, 2007

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APEC-0011

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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