Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD. - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2005

Last Updated Date

July 26, 2007

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

Changes in visual acuity from baseline.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00148551 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Change in lesion characteristics from baseline.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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.

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.

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Age-Related Macular Degeneration

Intervention ^†

Drug: Triamcinolone Acetonide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

120

Estimated Completion Date

March 2008

Primary Completion Date

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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00148551

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Canadian Retinal Trials Group

Collaborators ^††

University of British Columbia
QLT Inc
Vancouver Hospital

Investigators ^†

Study Director:

David A Maberley, M.D.

University of British Columbia

Information Provided By

Canadian Retinal Trials Group

Verification Date

July 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.