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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371111
First Posted: September 1, 2006
Last Update Posted: July 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Resorbed CME in OCT [ Time Frame: every 3 month ]
  • Resorbed CME in clinical examination [ Time Frame: Every 3 month ]

Secondary Outcome Measures:
  • need to retreatment [ Time Frame: when ever needed ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371111


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

ClinicalTrials.gov Identifier: NCT00371111     History of Changes
Other Study ID Numbers: 8524
First Submitted: August 31, 2006
First Posted: September 1, 2006
Last Update Posted: July 30, 2008
Last Verified: July 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
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
Bevacizumab
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action