Back to resultsTriamcinolone Acetonide as an Adjunctive to VPDT in ARMD.
Primary Purpose
Age-Related Macular Degeneration
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring AMD, Triamcinolone, Macular Degeneration
Eligibility 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.
Sites / Locations
- Eye Care Centre
Outcomes
Primary Outcome Measures
Changes in visual acuity from baseline.
Secondary Outcome Measures
Change in lesion characteristics from baseline.
Full Information
NCT ID
NCT00148551
First Posted
September 6, 2005
Last Updated
July 26, 2007
Sponsor
Canadian Retinal Trials Group
Collaborators
University of British Columbia, QLT Inc., Vancouver Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00148551
Brief Title
Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD.
Official Title
Triamcinolone Acetonide as an Adjunctive Treatment to Verteporfin Therapy in Neovascular Age-Related Macular Degeneration: Randomized Placebo-Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Canadian Retinal Trials Group
Collaborators
University of British Columbia, QLT Inc., Vancouver Hospital
4. Oversight
5. Study Description
Brief Summary
A 24 - month Study looking at the the changes in visual acuity of patients receiving PDT therapy in conjunction with intravitreal triamcinolone.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
AMD, Triamcinolone, Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Primary Outcome Measure Information:
Title
Changes in visual acuity from baseline.
Secondary Outcome Measure Information:
Title
Change in lesion characteristics from baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Maberley, M.D.
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Eye Care Centre
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
19748675
Citation
Maberley D; Canadian Retinal Trials Group. Photodynamic therapy and intravitreal triamcinolone for neovascular age-related macular degeneration: a randomized clinical trial. Ophthalmology. 2009 Nov;116(11):2149-57.e1. doi: 10.1016/j.ophtha.2009.04.032. Epub 2009 Sep 12.
Results Reference
derived
Learn more about this trial
Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD.
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