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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Shahid Beheshti Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00371111
First received: August 31, 2006
Last updated: July 28, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Resistant Cystoid Macular Edema
Drug: Intravitreal injection of Triamcinolone
Drug: Intravitreal injection of Avastin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • Resorbed CME in OCT [ Time Frame: every 3 month ] [ Designated as safety issue: No ]
  • Resorbed CME in clinical examination [ Time Frame: Every 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • need to retreatment [ Time Frame: when ever needed ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2006
Estimated Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intravitreal injection of Triamcinolone
Drug: Intravitreal injection of Triamcinolone
4 mg of Triamcinolone
Active Comparator: 2
Intravitreal injection of Avastin
Drug: Intravitreal injection of Avastin
Injection of 1.25 mg of Avastin and

Detailed Description:

This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371111

Locations
Iran, Islamic Republic of
Masoud Soheilian , MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti Medical University
Investigators
Principal Investigator: Masoud Soheilian, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00371111     History of Changes
Other Study ID Numbers: 8524
Study First Received: August 31, 2006
Last Updated: July 28, 2008
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
Resistant uveitic cystoid macular edema
intravitreal triamcinolone
intravitreal bevacizumab

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
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

ClinicalTrials.gov processed this record on September 16, 2014