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Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

Primary Purpose

* Diffuse Diabetic Macular Edema

Status

Unknown status

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Bevacizumab + Pars plana vitrectomy

Bevacizumab + pars plana vitrectomy

About this trial

This is an interventional treatment trial for * Diffuse Diabetic Macular Edema focused on measuring edema, retinal thickness, diabetic retinopathy

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Older than 25 yo
Diffuse diabetic macular edema with or without previous treatment

Exclusion Criteria:

Another retinal disease
Pregnancy

Sites / Locations

Asociacion para Evitar la Ceguera en Mexico I.A.P.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Renal disease

Without renal disease

Outcomes

Primary Outcome Measures

Retinal thickness

Secondary Outcome Measures

Visual acuity

Full Information

NCT ID

NCT00571142

First Posted

December 7, 2007

Last Updated

December 7, 2007

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00571142

Brief Title

Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

Official Title

Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and visual acuity in patients with diffuse diabetic macular edema and their relation to renal disease.

6. Conditions and Keywords

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

* Diffuse Diabetic Macular Edema

Keywords

edema, retinal thickness, diabetic retinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Renal disease

Arm Title

Arm Type

Active Comparator

Arm Description

Without renal disease

Intervention Type

Procedure

Intervention Name(s)

Bevacizumab + Pars plana vitrectomy

Intervention Description

2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.

Intervention Type

Procedure

Intervention Name(s)

Bevacizumab + pars plana vitrectomy

Intervention Description

2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy

Primary Outcome Measure Information:

Title

Retinal thickness

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Visual acuity

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Older than 25 yo Diffuse diabetic macular edema with or without previous treatment Exclusion Criteria: Another retinal disease Pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Veronica Kon-Jara, MD

Phone

5215537291895

veronicakon@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Antonieta Burgoa

Phone

10841400

Ext

1171

retinamex@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veronica Kon-Jara, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asociacion para Evitar la Ceguera en Mexico I.A.P.

City

Mexico

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ma Ana Martinez-Castellanos, MD

First Name & Middle Initial & Last Name & Degree

Oscar Alvarez-Verduzco, MD

First Name & Middle Initial & Last Name & Degree

Jose Luis Guerrero-Naranjo, MD

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz-Mercado, MD

12. IPD Sharing Statement

Learn more about this trial

Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

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