Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

This study is ongoing, but not recruiting participants.

First Received: June 30, 2006 Last Updated: January 3, 2007 History of Changes

Sponsor:	Asociación para Evitar la Ceguera en México
Information provided by:	Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:	NCT00417716

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetes Edema

Drug Information available for: Bevacizumab

U.S. FDA Resources

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

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417716

Locations

Mexico, Distrito Federal
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

No publications provided

Study ID Numbers:	APEC-0011
Study First Received:	June 30, 2006
Last Updated:	January 3, 2007
ClinicalTrials.gov Identifier:	NCT00417716 History of Changes
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Asociación para Evitar la Ceguera en México:

Diffuse Diabetic Macular Edema
Intravitreal Bevacizumab
Anti-VEGF drugs

Additional relevant MeSH terms:

Metabolic Diseases
Antineoplastic Agents
Growth Substances
Eye Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Edema
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Bevacizumab

Angiogenesis Inhibitors
Pharmacologic Actions
Macular Edema
Signs and Symptoms
Therapeutic Uses
Diabetes Mellitus, Type 2
Growth Inhibitors
Angiogenesis Modulating Agents
Glucose Metabolism Disorders
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010