Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO - Tabular View

Tracking Information

First Received Date ^ICMJE

November 30, 2007

Last Updated Date

November 30, 2007

Start Date ^ICMJE

June 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Changes in Best corrected visual acuity and macular edema measured with OCT [ Time Frame: Follow up to 3 , 6 and 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Report treatment complications [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO

Official Title ^ICMJE

Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion

Brief Summary

Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Detailed Description

Comparison of two groups with different treatment with registrations of outcome in BCVA and complications

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Macular Edema
Central Retinal Vein Occlusion

Intervention ^ICMJE

Drug: bevacizumab and triamcinolone

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

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Macular edema secondary to central retinal vein occlusion
BCVA worse than 20/40
Central macular >250 mc with OCT

Exclusion Criteria:

Diabetic retinopathy or other retinopathy
Media opacity that does not allow following
steroid responder
diagnosed glaucoma or IOP > 21 mmHg

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Carmen Conzalez-Mijares, Physician

5517638245

cacegomi@hotmail.com

Location Countries ^ICMJE

Mexico

Administrative Information

NCT ID ^ICMJE

NCT00566761

Responsible Party

Carmen Cecilia Gonzalez Mijares, Asociación para Evitar la Ceguera en Mexico IAP

Study ID Numbers ^ICMJE

MECRVO

Study Sponsor ^ICMJE

Asociación para Evitar la Ceguera en México

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Carmen Gonzalez-Mijares, Physician	APEC
Study Director:	Hugo Quiroz-Mercado, Retinologyst	APEC
Study Chair:	Juan Manuel Jimenez Sierra, Retinologyst	APEC
Study Chair:	MA Martinez-Castellanos, Physician	APEC
Study Chair:	Octavio Burgos Vejar, Physician	APEC
Study Chair:	Raul Velez-Montoya, Physician	APEC
Study Chair:	Ma de Lourdes Lopez Ramos, Physician	APEC
Study Chair:	Omar Honerlager, preresident	APEC

Information Provided By

Asociación para Evitar la Ceguera en México

Verification Date

November 2007

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