Intravitreal Bevacizumab for Diabetic Retinopathy

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. Identifier: NCT00600262
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : January 24, 2008
Information provided by:
Asociación para Evitar la Ceguera en México

Brief Summary:

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 or disease Intervention/treatment Phase
Severe Nonproliferative Proliferative Diabetic Retinopathy Active Photocoagulated Diabetic Retinopathy Drug: intravitreal bevacizumab Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
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.
Study Start Date : December 2005
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00600262

Elizabeth Reyna Castelan
Mexico City, Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
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 Identifier: NCT00600262     History of Changes
Other Study ID Numbers: APEC-004
First Posted: January 24, 2008    Key Record Dates
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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents