Back to results

Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Primary Purpose

Diabetes Mellitus Type 2, Diabetic Macular Edema

Status

Unknown status

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Intravitreal Bevacizumab

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Diffuse Diabetic Macular Edema, Intravitreal Bevacizumab, Anti-VEGF drugs

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Asociación para Evitar la Ceguera en México

Outcomes

Primary Outcome Measures

BCVA

Fluorescein Angiography

Optical Coherence Tomography

Secondary Outcome Measures

Full Information

NCT ID

NCT00417716

First Posted

June 30, 2006

Last Updated

January 3, 2007

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00417716

Brief Title

Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2006

Overall Recruitment Status

Unknown status

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

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

Diabetes Mellitus Type 2, Diabetic Macular Edema

Keywords

Diffuse Diabetic Macular Edema, Intravitreal Bevacizumab, Anti-VEGF drugs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Intravitreal Bevacizumab

Primary Outcome Measure Information:

Title

BCVA

Title

Fluorescein Angiography

Title

Optical Coherence Tomography

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adriana Solís-Vivanco, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jans Fromow-Guerra, MD PhD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Elizabeth Reyna-Castelán

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Juan M Jiménez-Sierra, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Myriam Hernández-Rojas, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Griselda Alvarez-Rivera, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz-Mercado, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Director

Facility Information:

Facility Name

Asociación para Evitar la Ceguera en México

City

Mexico city

State/Province

Distrito Federal

ZIP/Postal Code

04030

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

We'll reach out to this number within 24 hrs