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

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

This study is currently recruiting participants.

Verified by Asociación para Evitar la Ceguera en México, November 2007

First Received: November 30, 2007 No Changes Posted

Sponsor:	Asociación para Evitar la Ceguera en México
Information provided by:	Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:	NCT00566761

Purpose

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

Condition	Intervention	Phase
Macular Edema Central Retinal Vein Occlusion	Drug: bevacizumab and triamcinolone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Bevacizumab Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	10
Study Start Date:	June 2007
Estimated Study Completion Date:	March 2008

Intervention Details:

three applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2

Detailed Description:

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566761

Contacts

Contact: Carmen Conzalez-Mijares, Physician

5517638245

cacegomi@hotmail.com

Locations

Mexico, Coyoacan
Asociacion Para Evitar la Ceguera en Mexico	Recruiting
Mexico city, Coyoacan, Mexico, 04030
Contact: Retina Department 5510841400 ext 1171 retinamex@yahoo.com

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México

Investigators

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

More Information

No publications provided

Responsible Party:	Asociación para Evitar la Ceguera en Mexico IAP ( Carmen Cecilia Gonzalez Mijares )
Study ID Numbers:	MECRVO
Study First Received:	November 30, 2007
Last Updated:	November 30, 2007
ClinicalTrials.gov Identifier:	NCT00566761 History of Changes
Health Authority:	Mexico: Ethics Committee

Keywords provided by Asociación para Evitar la Ceguera en México:

Macular edema
central retinal vein occlusion
bevacizumab
triamcinolone

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Bevacizumab
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Macular Edema
Triamcinolone Acetonide
Retinal Vein Occlusion
Therapeutic Uses

Triamcinolone
Cardiovascular Diseases
Venous Thrombosis
Growth Inhibitors
Angiogenesis Modulating Agents
Retinal Diseases
Growth Substances
Eye Diseases
Vascular Diseases
Retinal Degeneration
Macular Degeneration
Enzyme Inhibitors
Triamcinolone diacetate
Angiogenesis Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 08, 2010