Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD.

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2007 by Canadian Retinal Trials Group. Recruitment status was Active, not recruiting

First Received on September 6, 2005. Last Updated on July 26, 2007 History of Changes

Sponsor:	Canadian Retinal Trials Group
Collaborators:	University of British Columbia QLT Inc Vancouver Hospital
Information provided by:	Canadian Retinal Trials Group
ClinicalTrials.gov Identifier:	NCT00148551

Purpose

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

Condition	Intervention	Phase
Age-Related Macular Degeneration	Drug: Triamcinolone Acetonide	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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.

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Canadian Retinal Trials Group:

Primary Outcome Measures:

Changes in visual acuity from baseline.

Secondary Outcome Measures:

Change in lesion characteristics from baseline.

Estimated Enrollment:	120
Study Start Date:	January 2004
Estimated Study Completion Date:	March 2008

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148551

Locations

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

Study Director:

David A Maberley, M.D.

University of British Columbia

More Information

No publications provided by Canadian Retinal Trials Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2009 Sep 12.

ClinicalTrials.gov Identifier:	NCT00148551 History of Changes
Other Study ID Numbers:	01 (C03 - 0236)
Study First Received:	September 6, 2005
Last Updated:	July 26, 2007
Health Authority:	Canada: Health Canada

Keywords provided by Canadian Retinal Trials Group:

AMD
Triamcinolone
Macular Degeneration

Additional relevant MeSH terms:

Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses

Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012