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

• Sponsor: Asociación para Evitar la Ceguera en México (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00566761
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema; Central Retinal Vein Occlusion	Drug: bevacizumab and triamcinolone	Phase 4

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jun 1, 2007
• Anticipated Study Completion Date: Mar 1, 2008

Outcome Measures

Primary Outcome Measures

1. Changes in Best corrected visual acuity and macular edema measured with OCT [Follow up to 3 , 6 and 12 months]

Secondary Outcome Measures

1. Report treatment complications [12 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Asociacion Para Evitar la Ceguera en Mexico	Mexico city	Coyoacan	Mexico	04030

Sponsors and Collaborators

• Asociación para Evitar la Ceguera en México

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00566761
• Other Study ID Numbers: MECRVO
• First Posted: Dec 4, 2007
• Last Update Posted: Dec 4, 2007
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: Macular edema; central retinal vein occlusion; bevacizumab; triamcinolone
• Additional relevant MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema; Triamcinolone; Bevacizumab

Study Results

No Results Posted as of Dec 4, 2007