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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00305630
First Posted: March 22, 2006
Last Update Posted: March 22, 2006
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.
Collaborator:
Oregon Health and Science University
Information provided by:
Johns Hopkins University
  Purpose
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 Intervention Phase
Choroidal Neovascularization Age-Related Macular Degeneration Drug: Periocular injection of triamcinolone acetonide 40mg Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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

Secondary Outcome Measures:
  • Safety

Estimated Enrollment: 100
Study Start Date: July 2002
Estimated Study Completion Date: November 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00305630


Locations
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
Investigators
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
  More Information

ClinicalTrials.gov Identifier: NCT00305630     History of Changes
Other Study ID Numbers: IND 64263
First Submitted: March 20, 2006
First Posted: March 22, 2006
Last Update Posted: March 22, 2006
Last Verified: March 2006

Keywords provided by Johns Hopkins University:
Corticosteroids
Triamcinolone
Photodynamic therapy
Choroidal neovascularization
Age-related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action