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Unilateral Bevacizumab for Bilateral Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT00496405
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : October 12, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The endothelial growth factor (VEGF), has been implied in the genesis of diverse Neovascular disease. In the industrialized and developing countries, the main cause of blindness is the diabetic retinopathy. Bevacizumab (Avastin, genentech, Inc., San Francisco, California, the USA) is a drug.In the last years its use "off-label", in ophthalmology field, has become popular. This is due to its proven safeness and effectiveness for the treatment of diverse ocular diseases. A lot has been speculated about the systemic absorption of Bevacizumab. It is for that reason that the objective of this study is the systematic and random revision of the fellows eyes, of the patients programmed for the intravitreal administration of Bevacizumab, with bilateral macular edema. In such a way that the therapeutic value in the fellow eye of bevacizumab can be determined

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Diabetic Retinopathy Drug: bevacizumab Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Role of Unilateral Intravitreal Bevacizumab (Avastin), for the Treatment of Bilateral Diabetic Macular Edema: a Pilot Study.
Study Start Date : April 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Retinal thickness [ Time Frame: Interventional ]

Secondary Outcome Measures :
  1. Best corrected visual acuity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient greater of 30 years old, with bilateral diffuse diabetic macular edema, with any degree of diabetic retinopathy that has been programmed for Bevacizumab intravitreal administration in one of both eyes.
  • Bilateral macular Thickening, measured by OCT of 225mm or bigger.
  • Pupil dilatation greater than 5mm.
  • Patient with no previous treatment for diabetic macular edema.

Exclusion Criteria:

  • Focal diabetic macular edema or macular edema of different etiology, besides diabetes. (uveitis, pseudophakic patients, vitreous-retinal traction, CRVO, BRVO, CSC).
  • Macular edema 3B patter, measured by OCT, according to the macular edema classification.
  • Medical history of severe thromboembolic events, uncontrolled arterial hypertension, transitory ischemic attacks, cardiac stroke, acute cerebral vascular event.
  • Pregnant women or breast feeding women
  • Know allergy to Bevacizumab
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): NCT00496405


Locations
Mexico
Asociación para Evitar la Ceguera en Mexico
Mexico, DF, Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Raul Velez-Montoya, MD Asociación para Evitar la Ceguera en Mexico
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00496405     History of Changes
Other Study ID Numbers: APEC
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: October 12, 2007
Last Verified: October 2007

Keywords provided by Asociación para Evitar la Ceguera en México:
Vascular endothelial growth factor.
Retinal Thickness
Diabetic Macular Edema
Optical Coherent Tomography

Additional relevant MeSH terms:
Edema
Macular Edema
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents