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Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00417716
First received: June 30, 2006
Last updated: January 3, 2007
Last verified: June 2006
History of Changes

June 30, 2006
January 3, 2007
September 2005
Not Provided
  • BCVA
  • Fluorescein Angiography
  • Optical Coherence Tomography
Same as current
Complete list of historical versions of study NCT00417716 on ClinicalTrials.gov Archive Site
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Not Provided
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Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema
The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema

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.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus Type 2
  • Diabetic Macular Edema
Drug: Intravitreal Bevacizumab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
May 2006
Not Provided

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)
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00417716
APEC-0011
Not Provided
Not Provided
Asociación para Evitar la Ceguera en México
Not Provided
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
Asociación para Evitar la Ceguera en México
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP