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Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00417716
First Posted: January 4, 2007
Last Update Posted: January 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asociación para Evitar la Ceguera en México
  Purpose
Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema

Condition Intervention Phase
Diabetes Mellitus Type 2 Diabetic Macular Edema Drug: Intravitreal Bevacizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • BCVA
  • Fluorescein Angiography
  • Optical Coherence Tomography

Estimated Enrollment: 45
Study Start Date: September 2005
Estimated Study Completion Date: May 2006
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417716


Locations
Mexico
Asociación para Evitar la Ceguera en México
Mexico city, Distrito Federal, Mexico, 04030
Sponsors and Collaborators
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: 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 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
  More Information

ClinicalTrials.gov Identifier: NCT00417716     History of Changes
Other Study ID Numbers: APEC-0011
First Submitted: June 30, 2006
First Posted: January 4, 2007
Last Update Posted: January 4, 2007
Last Verified: June 2006

Keywords provided by Asociación para Evitar la Ceguera en México:
Diffuse Diabetic Macular Edema
Intravitreal Bevacizumab
Anti-VEGF drugs

Additional relevant MeSH terms:
Diabetes Mellitus
Edema
Macular Edema
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents