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Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD.

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ClinicalTrials.gov Identifier: NCT00148551
Recruitment Status : Unknown
Verified July 2007 by Canadian Retinal Trials Group.
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : July 30, 2007
Sponsor:
Collaborators:
University of British Columbia
QLT Inc.
Vancouver Hospital
Information provided by:
Canadian Retinal Trials Group

Study Description
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Brief Summary:
A 24 - month Study looking at the the changes in visual acuity of patients receiving PDT therapy in conjunction with intravitreal triamcinolone.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Triamcinolone Acetonide Phase 2 Phase 3

Detailed Description:
This study will evaluate the effect of Triamcinolone Acetonide in conjunction with photodynamic therapy for the treatment of sub-foveal choroidal neovascular membranes secondary to age-related macular degeneration.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Triamcinolone Acetonide as an Adjunctive Treatment to Verteporfin Therapy in Neovascular Age-Related Macular Degeneration: Randomized Placebo-Controlled Clinical Trial.
Study Start Date : January 2004
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Changes in visual acuity from baseline.

Secondary Outcome Measures :
  1. Change in lesion characteristics from baseline.

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:

  • Individuals with predominantly classic, subfoveal CNV secondary to AMD.
  • No previous PDT Treatment in study eye.

Exclusion Criteria:

  • CNV from conditions, other than AMD.
  • Other disease that could be responsible for decreased vision.
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): NCT00148551


Locations
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Canada, British Columbia
Eye Care Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Canadian Retinal Trials Group
University of British Columbia
QLT Inc.
Vancouver Hospital
Investigators
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Study Director: David A Maberley, M.D. University of British Columbia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00148551    
Other Study ID Numbers: 01 (C03 - 0236)
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: July 30, 2007
Last Verified: July 2007
Keywords provided by Canadian Retinal Trials Group:
AMD
Triamcinolone
Macular Degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action