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Intravitreal Bevacizumab vs. Bevacizumab Combined With Triamcinolone for Neovascular AMD

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.
 
ClinicalTrials.gov Identifier: NCT00370370
Recruitment Status : Unknown
Verified June 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2006
Last Update Posted : June 26, 2008
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Study Description
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Brief Summary:
To compare the efficacy and safety results of intravitreal bevacizumab alone with bevacizumab + triamcinolone acetonide in neovascular AMD.

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration Drug: bevacizumab Drug: bevacizumab + triamcinolone acetonide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : November 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Injection of intravitreal bevacizumab
 Drug: bevacizumab
Injection of intravitreal bevacizumab
Active Comparator: 2
Injection of bevacizumab + triamcinolone acetonide
 Drug: bevacizumab + triamcinolone acetonide
Injection of bevacizumab + triamcinolone acetonide


Outcome Measures
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Primary Outcome Measures :
  1. visual acuity

Secondary Outcome Measures :
  1. central macular thickness
  2. leakage in fluorescein angiography
  3. intraocular pressure
  4. anterior chamber reaction

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cases of active neovascular AMD with visual acuity of 20/400- 20/40

Exclusion Criteria:

  • History of glaucoma or ocular hypertension
  • Disciform scar
Contacts and Locations
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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): NCT00370370


Locations
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Iran, Islamic Republic of
Hamid Ahmadieh, MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
More Information
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ClinicalTrials.gov Identifier: NCT00370370    
Other Study ID Numbers: 8533
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: June 26, 2008
Last Verified: June 2008
Keywords provided by Shahid Beheshti University of Medical Sciences:
Bevacizumab,
Triamcinolone
Age-related macular degeneration
Choroidal neovascular membrane
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Bevacizumab
Triamcinolone diacetate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action