Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone...
Date First Received: November 30, 2007
Last Updated: November 30, 2007
Verified by: Asociación para Evitar la Ceguera en México, November 2007
Clinical Trial Phase: Phase 4 | Start Date: June 2007
Overall Status: Recruiting
Estimated Enrollment: 10
Brief Summary
Official Title: “Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion”
Condition Keyword(s):
Intervention(s):
Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
Comparison of two groups with different treatment with registrations of outcome in BCVA and complications
Intervention(s) in this Clinical Trial
- Drug: bevacizumab and triamcinolone
- 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
Outcome Measures for this Clinical Trial
Primary Measures
- Changes in Best corrected visual acuity and macular edema measured with OCT
- Time Frame: Follow up to 3 , 6 and 12 months
Safety Issue?: No
- Time Frame: Follow up to 3 , 6 and 12 months
Secondary Measures
- Report treatment complications
- Time Frame: 12 month
Safety Issue?: No
- Time Frame: 12 month
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Asociación para Evitar la Ceguera en México
Overall Clinical Trial Officials and Contacts
Carmen Gonzalez-Mijares, Physician Principal Investigator APEC
Overall Contact: Carmen Conzalez-Mijares, Physician 5517638245 cacegomi@hotmail.com
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00566761
Study ID Number: MECRVO
ClinicalTrials.gov Identifier: NCT00566761
Health Authority: Mexico: Ethics Committee
Clinical Trials Authorship and Review
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