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

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ClinicalTrials.gov Identifier: NCT00371111
Recruitment Status : Unknown
Verified July 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2006
Last Update Posted : July 30, 2008
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Resistant Cystoid Macular Edema Drug: Intravitreal injection of Triamcinolone Drug: Intravitreal injection of Avastin Phase 1

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : August 2006
Actual Primary Completion Date : May 2008
Estimated Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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

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

ClinicalTrials.gov Identifier: NCT00371111     History of Changes
Other Study ID Numbers: 8524
First Posted: September 1, 2006    Key Record Dates
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