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NCT00417716 Clinical Trial

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Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00417716
Other study ID # APEC-0011
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date September 2005
Est. completion date May 2006

Study information
Verified date May 2024
Source Asociación para Evitar la Ceguera en México
Contact n/a
Is FDA regulated No
Health authority
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Status Withdrawn
Enrollment 0
Est. completion date May 2006
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender All
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

Related Conditions & MeSH terms

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
See also
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Completed NCT02221453 - Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide Phase 2
Completed NCT02979665 - Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
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Completed NCT00683176 - Effect of Choline Fenofibrate (SLV348) on Macular Edema Phase 2
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