Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00417716
• Other study ID #: APEC-0011
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 30, 2006
• Last updated: January 3, 2007
• Start date: September 2005
• Est. completion date: May 2006

Study information

• Verified date: June 2006
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Intravitreal Bevacizumab

Locations

Country	Name	City	State
Mexico	Asociación para Evitar la Ceguera en México	Mexico city	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA
Primary	Fluorescein Angiography
Primary	Optical Coherence Tomography