Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD.

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

Date First Received: September 6, 2005

Last Updated: July 26, 2007

Verified by: Canadian Retinal Trials Group, July 2007

Clinical Trial Phase: Phase 2/Phase 3 | Start Date: January 2004

Overall Status: Active, not recruiting

Estimated Enrollment: 120

Brief Summary

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

Condition Keyword(s):

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

Study Type: Interventional

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

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: Triamcinolone Acetonide

Outcome Measures for this Clinical Trial

Primary Measures

  • Changes in visual acuity from baseline.

Secondary Measures

  • Change in lesion characteristics from baseline.

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Canadian Retinal Trials Group

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00148551

Study ID Number: 01 (C03 - 0236)

ClinicalTrials.gov Identifier: NCT00148551

Health Authority: Canada: Health Canada

Clinical Trials Authorship and Review

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