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NCT00600262 Clinical Trial

Intravitreal Bevacizumab for Diabetic Retinopathy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:
Efficacy of Intravitreal Bevacizumab for Severe Nonproliferative and Proliferative Diabetic Retinopathy.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00600262
Other study ID # APEC-004
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date December 2005
Est. completion date June 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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• intravitreal bevacizumab

Locations
Country Name City State
Mexico Elizabeth Reyna Castelan Mexico City

Sponsors (1)
Lead Sponsor Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

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