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)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2007 by Asociación para Evitar la Ceguera en México. Recruitment status was Recruiting

First Received on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: age-related macular degeneration 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
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:	Carmen Cecilia Gonzalez Mijares, Asociación para Evitar la Ceguera en Mexico IAP
ClinicalTrials.gov Identifier:	NCT00566761 History of Changes
Other Study ID Numbers:	MECRVO
Study First Received:	November 30, 2007
Last Updated:	November 30, 2007
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:

Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone hexacetonide
Triamcinolone

Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012