Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD. | NCT00148551

Studies
Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD.

NCT00148551

Sponsor

Canadian Retinal Trials Group

Status

Unknown status

Last Update Posted

Jul 30, 2007Estimated

Enrollment

120Estimated

Phase

Phase 2Phase 3

Conditions

Age-Related Macular Degeneration

Interventions

Triamcinolone Acetonide

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Mar 2008Estimated

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2007

Last Update Posted Date

Jul 30, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Canadian Retinal Trials GroupOTHER

Collaborators

Name	Class
University of British Columbia	OTHER
QLT Inc.	INDUSTRY
Vancouver Hospital	UNKNOWN

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Name	Type	Description	Arm Group Labels	Other Names
Triamcinolone Acetonide	Drug

Measure	Description	Time Frame
Changes in visual acuity from baseline.

Measure	Description	Time Frame
Change in lesion characteristics from baseline.

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Care Centre		Vancouver	British Columbia		Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19748675	Derived	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. doi: 10.1016/j.ophtha.2009.04.032. Epub 2009 Sep 12.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D014221	Triamcinolone
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473