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Intravitreal Bevacizumab for Diabetic Retinopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600262
First Posted: January 24, 2008
Last Update Posted: January 24, 2008
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

Background: to evaluate the 3-month efficacy of a single dose of intravitreal bevacizumab on the progression of severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy and active photocoagulated diabetic proliferative by evaluation of ischemic areas and regression of retinal and disc neovasculrization.

Methods: 40 patients were enrolled in a prospective, interventional study. Patients were treated with intravitreal bevacizumab 0.1ml (0.25mg). We evaluated visual acuity, neovascularization leakage points, capillary closure ischemic areas and macular edema by clinical examination and fluorescein angiography. A clinical examination was performed at baseline and days 1,14 and 30. Active leakage points were measured by fluorescein angiography at 30 days.


Condition Intervention Phase
Severe Nonproliferative Proliferative Diabetic Retinopathy Active Photocoagulated Diabetic Retinopathy Drug: intravitreal bevacizumab Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Intravitreal Bevacizumab for Severe Nonproliferative and Proliferative Diabetic Retinopathy.

Resource links provided by NLM:


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

Study Start Date: December 2005
Estimated Study Completion Date: June 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe nonproliferative
  • Proliferative diabetic retinopathy
  • Active photocoagulated diabetic retinopathy

Exclusion Criteria:

  • Previous vascular occlusion
  • Glaucoma
  • Uncontrolled hypertension, thromboembolic event
  • Renal abnormalities
  • Recent or planned surgery
  • Coagulation abnormalities
  • Panretinal photocoagulation of less than one month before
  • Patients with known serious allergies
  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): NCT00600262


Locations
Mexico
Elizabeth Reyna Castelan
Mexico City, Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Elizabeth Reyna-Castelan, MD Asociación para evitar la ceguera en Mexico
Study Chair: Mariana Martinez-Castellanos, MD Asociación para Evitar la Ceguera en México
  More Information

ClinicalTrials.gov Identifier: NCT00600262     History of Changes
Other Study ID Numbers: APEC-004
First Submitted: June 29, 2006
First Posted: January 24, 2008
Last Update Posted: January 24, 2008
Last Verified: January 2008

Keywords provided by Asociación para Evitar la Ceguera en México:
severe nonproliferative
proliferative diabetic retinopathy
active photocoagulated diabetic retinopathy
intravitreal bevacizumab

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
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