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Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

Primary Purpose

Diffuse Diabetic Macular Edema

Status

Unknown status

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Triamcinolone Acetonide and Bevacizumab

About this trial

This is an interventional treatment trial for Diffuse Diabetic Macular Edema focused on measuring Macula, Edema

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

Diffuse diabetic macular edema
Non proliferative diabetic retinopathy
No VPP previa
No previous treament with laser, Triamcinolone acetonide, and Bevacizumab

Exclusion Criteria:

Proliferative diabetic retinopathy
Previous pars plana vitrectomy
Previous treatment with diabetic macular edema
Focal macular edema
Macular Ischemia

Sites / Locations

Asociacion Para Evitar la Ceguera en MexicoRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00600301

First Posted

June 30, 2006

Last Updated

January 23, 2008

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00600301

Brief Title

Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Unknown status

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

5. Study Description

Brief Summary

Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.

6. Conditions and Keywords

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

Diffuse Diabetic Macular Edema

Keywords

Macula, Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

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)

Triamcinolone Acetonide and Bevacizumab

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Eligibility Criteria

Inclusion Criteria: Diffuse diabetic macular edema Non proliferative diabetic retinopathy No VPP previa No previous treament with laser, Triamcinolone acetonide, and Bevacizumab Exclusion Criteria: Proliferative diabetic retinopathy Previous pars plana vitrectomy Previous treatment with diabetic macular edema Focal macular edema Macular Ischemia

Central Contact Person:

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

Maximiliano Gordon, MD

Phone

10841400

Ext

1171, 1172

retinamex@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maximiliano Gordon, 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

City

Mexico D.F.

State/Province

D.f.

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maximiliano Gordon, MD

Phone

10841400

Ext

1171, 1172

retinamex@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

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