Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)
Information source: Johns Hopkins University
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Choroidal Neovascularization; Age-Related Macular Degeneration
Intervention: Periocular injection of triamcinolone acetonide 40mg (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s):
Douglas A Jabs, MD, MBA, Study Chair, Affiliation: Johns Hopkins University
Neil M Bressler, MD, Principal Investigator, Affiliation: Johns Hopkins Univeristy School of Medicine
David J Wilson, MD, Principal Investigator, Affiliation: Oregon Health and Science University
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.
Clinical Details
Official title: Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
Secondary outcome: Safety
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Johns Hopkins Univeristy School of Medicine, Baltimore, Maryland 21287, United States
Oregon Health Science Univeristy, Portland, Oregon 97239, United States
Additional Information
Starting date: July 2002
Ending date: November 2005
Last updated: March 20, 2006
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