Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)
Primary Purpose
Choroidal Neovascularization, Age-Related Macular Degeneration
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Periocular injection of triamcinolone acetonide 40mg
Sponsored by
About this trial
This is an interventional treatment trial for Choroidal Neovascularization focused on measuring Corticosteroids, Triamcinolone, Photodynamic therapy, Choroidal neovascularization, Age-related macular degeneration
Eligibility Criteria
Inclusion Criteria: Active choroidal neovascularization Age related macular degeneration Visual acuity 20/20 to 20/400 Exclusion Criteria: Neovascular lesion >6500 microns is greatest linear diameter More than one prior photodynamic therapy treatment Receiving systemic corticosteroids Intraocular pressure > 21 mm Hg or glaucoma medication use History of glaucoma or history of ocular hypertension
Sites / Locations
- Johns Hopkins Univeristy School of Medicine
- Oregon Health Science Univeristy
Outcomes
Primary Outcome Measures
Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
Secondary Outcome Measures
Safety
Full Information
NCT ID
NCT00305630
First Posted
March 20, 2006
Last Updated
March 20, 2006
Sponsor
Johns Hopkins University
Collaborators
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00305630
Brief Title
Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)
Official Title
Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
Collaborators
Oregon Health and Science University
4. Oversight
5. Study Description
Brief Summary
Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months on fluorescein angiography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Age-Related Macular Degeneration
Keywords
Corticosteroids, Triamcinolone, Photodynamic therapy, Choroidal neovascularization, Age-related macular degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Periocular injection of triamcinolone acetonide 40mg
Primary Outcome Measure Information:
Title
Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
Secondary Outcome Measure Information:
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active choroidal neovascularization
Age related macular degeneration
Visual acuity 20/20 to 20/400
Exclusion Criteria:
Neovascular lesion >6500 microns is greatest linear diameter
More than one prior photodynamic therapy treatment
Receiving systemic corticosteroids
Intraocular pressure > 21 mm Hg or glaucoma medication use
History of glaucoma or history of ocular hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas A Jabs, MD, MBA
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Neil M Bressler, MD
Organizational Affiliation
Johns Hopkins Univeristy School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David J Wilson, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Univeristy School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Oregon Health Science Univeristy
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)
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