To Compare Therapeutic Effect of Intravitreal Bevacizumab and Triamcinolone in Resistant Uveitic Cystoid Macular Edema

Verified by: Shaheed Beheshti Medical University, July 2008
First Received: August 31, 2006 | Last Updated: July 28, 2008 | Phase: Phase 1 | Start Date: August 2006
Overall Status: Active, not recruiting | Estimated Enrollment: 40
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
  • 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
  • Resorbed CME in clinical examination
    • Time Frame: Every 3 month
      Safety Issue?: No

Secondary Measures

  • need to retreatment
    • Time Frame: when ever needed
      Safety Issue?: No

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 Investigator Information

Lead Investigator: Shaheed Beheshti Medical University Other

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 February 09, 2012

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00371111