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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 30, 2006

Last Updated Date

January 23, 2008

Start Date ^†

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00600301 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

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

Official Title ^†

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Diffuse Diabetic Macular Edema

Intervention ^†

Drug: Triamcinolone Acetonide and Bevacizumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

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

Gender

Both

Ages

20 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Maximiliano Gordon, MD

10841400 ext 1171, 1172

retinamex@yahoo.com

Location Countries ^†

Mexico

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600301

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Asociación para Evitar la Ceguera en México

Collaborators ^††

Investigators ^†

Principal Investigator:

Maximiliano Gordon, MD

APEC

Information Provided By

Asociación para Evitar la Ceguera en México

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.