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

Tracking Information

First Received Date ^ICMJE

June 30, 2006

Last Updated Date

January 23, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

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

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Diffuse Diabetic Macular Edema

Intervention ^ICMJE

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 ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact: Maximiliano Gordon, MD

10841400 ext 1171, 1172

retinamex@yahoo.com

Location Countries ^ICMJE

Mexico

Administrative Information

NCT ID ^ICMJE

NCT00600301

Responsible Party

Study ID Numbers ^ICMJE

APEC-OO13

Study Sponsor ^ICMJE

Asociación para Evitar la Ceguera en México

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Maximiliano Gordon, MD

APEC

Information Provided By

Asociación para Evitar la Ceguera en México

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP