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Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305630
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : March 22, 2006
Oregon Health and Science University
Information provided by:
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Age-Related Macular Degeneration Drug: Periocular injection of triamcinolone acetonide 40mg Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy
Study Start Date : July 2002
Study Completion Date : November 2005

Primary Outcome Measures :
  1. Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.

Secondary Outcome Measures :
  1. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00305630

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United States, Maryland
Johns Hopkins Univeristy School of Medicine
Baltimore, Maryland, United States, 21287
United States, Oregon
Oregon Health Science Univeristy
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Johns Hopkins University
Oregon Health and Science University
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Study Chair: Douglas A Jabs, MD, MBA Johns Hopkins University
Principal Investigator: Neil M Bressler, MD Johns Hopkins Univeristy School of Medicine
Principal Investigator: David J Wilson, MD Oregon Health and Science University

Layout table for additonal information Identifier: NCT00305630     History of Changes
Other Study ID Numbers: IND 64263
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: March 22, 2006
Last Verified: March 2006
Keywords provided by Johns Hopkins University:
Photodynamic therapy
Choroidal neovascularization
Age-related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action