Cystoid macular edema (CME) is one of the common causes of vision loss in patients with UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision. Also there are some documents which recommend Bevacizumab(avastin) could reduce macular edema. This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular...
Date First Received: August 31, 2006
Last Updated: July 28, 2008
Verified by: Shaheed Beheshti Medical University, July 2008
Clinical Trial Phase: Phase 1 | Start Date: August 2006
Overall Status: Active, not recruiting
Estimated Enrollment: 40
Brief Summary
Condition Keyword(s):
Cystoid macular edema (CME) is one of the common causes of vision loss in patients with UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision.
Also there are some documents which recommend Bevacizumab(avastin) could reduce macular edema. This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: May 2008
Detailed Clinical Trial Description
This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.
Intervention(s) in this Clinical Trial
- Drug: Intravitreal injection of Triamcinolone
- 4 mg of Triamcinolone
- Drug: Intravitreal injection of Avastin
- Injection of 1.25 mg of Avastin and
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Intravitreal injection of Triamcinolone
- Active Comparator: 2
- Intravitreal injection of Avastin
Outcome Measures for this Clinical Trial
Primary Measures
- Resorbed CME in OCT
- Time Frame: every 3 month
Safety Issue?: No
- Time Frame: every 3 month
- Resorbed CME in clinical examination
- Time Frame: Every 3 month
Safety Issue?: No
- Time Frame: Every 3 month
Secondary Measures
- need to retreatment
- Time Frame: when ever needed
Safety Issue?: No
- Time Frame: when ever needed
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Uveitic CME
- Uveitic CME refractory to routine treatment
- Vision better than 5/200 and worse than 20/50
Exclusion Criteria:
- Mono- Ocular patients
- History of vitrectomy
- Glaucoma or ocular hypertension
- History of other retinal disease that can cause macular edema
- Pregnancy
- Significant media opacity
- Vision better than 20/50
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: Shaheed Beheshti Medical University
Overall Clinical Trial Officials and Contacts
Masoud Soheilian, MD Principal Investigator Ophthalmic Research Center of Shaheed Beheshti Medical University
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00371111
Study ID Number: 8524
ClinicalTrials.gov Identifier: NCT00371111
Health Authority: Iran: Ethics Committee
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
