Intravitreal Bevacizumab for Diabetic Retinopathy

Sponsor

Asociación para Evitar la Ceguera en México (Other)

Overall Status

Completed

CT.gov ID

NCT00600262

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Severe Nonproliferative Proliferative Diabetic Retinopathy Active Photocoagulated Diabetic Retinopathy	Drug: intravitreal bevacizumab	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2005

Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elizabeth Reyna Castelan	Mexico City		Mexico	04030

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México

Investigators

Principal Investigator: Elizabeth Reyna-Castelan, MD, Asociación para evitar la ceguera en Mexico
Study Chair: Mariana Martinez-Castellanos, MD, Asociación para Evitar la Ceguera en México