Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD.

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00148551
• Other study ID #: 01 (C03 - 0236)
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 6, 2005
• Last updated: July 26, 2007
• Start date: January 2004
• Est. completion date: March 2008

Study information

• Verified date: July 2007
• Source: Canadian Retinal Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Triamcinolone Acetonide

Locations

Country	Name	City	State
Canada	Eye Care Centre	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Canadian Retinal Trials Group	QLT Inc., University of British Columbia, Vancouver Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in visual acuity from baseline.
Secondary	Change in lesion characteristics from baseline.