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Intravitreal Bevacizumab for Diabetic Retinopathy

Primary Purpose

Severe Nonproliferative, Proliferative Diabetic Retinopathy, Active Photocoagulated Diabetic Retinopathy

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

intravitreal bevacizumab

About this trial

This is an interventional treatment trial for Severe Nonproliferative focused on measuring severe nonproliferative, proliferative diabetic retinopathy, active photocoagulated diabetic retinopathy, intravitreal bevacizumab

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Elizabeth Reyna Castelan

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00600262

First Posted

June 29, 2006

Last Updated

January 23, 2008

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00600262

Brief Title

Intravitreal Bevacizumab for Diabetic Retinopathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Nonproliferative, Proliferative Diabetic Retinopathy, Active Photocoagulated Diabetic Retinopathy

Keywords

severe nonproliferative, proliferative diabetic retinopathy, active photocoagulated diabetic retinopathy, intravitreal bevacizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

intravitreal bevacizumab

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Reyna-Castelan, MD

Organizational Affiliation

Asociación para evitar la ceguera en Mexico

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mariana Martinez-Castellanos, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

Facility Information:

Facility Name

Elizabeth Reyna Castelan

City

Mexico City

ZIP/Postal Code

04030

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

Intravitreal Bevacizumab for Diabetic Retinopathy

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