Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD.

July 26, 2007 updated by: Canadian Retinal Trials Group

Triamcinolone Acetonide as an Adjunctive Treatment to Verteporfin Therapy in Neovascular Age-Related Macular Degeneration: Randomized Placebo-Controlled Clinical Trial.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Eye Care Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Changes in visual acuity from baseline.

Secondary Outcome Measures

Outcome Measure
Change in lesion characteristics from baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Retinal Trials Group

Collaborators

QLT Inc.
University of British Columbia
Vancouver Hospital

Investigators

  • Study Director: David A Maberley, M.D., University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

July 30, 2007

Last Update Submitted That Met QC Criteria

July 26, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (C03 - 0236)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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