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Intravitreal Bevacizumab for Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00600262
First received: June 29, 2006
Last updated: January 23, 2008
Last verified: January 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Intravitreal Bevacizumab for Severe Nonproliferative and Proliferative Diabetic Retinopathy.

Resource links provided by NLM:

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

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Asociacion para evitar la ceguera en Mexico
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00600262     History of Changes
Other Study ID Numbers: APEC-004
Study First Received: June 29, 2006
Last Updated: January 23, 2008
Health Authority: Mexico: Secretaria de Salud

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:
Diabetic Retinopathy
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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013