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Sponsors and Collaborators: |
Johns Hopkins University Oregon Health and Science University |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00305630 |
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 II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Study ID Numbers: | IND 64263 |
Study First Received: | March 20, 2006 |
Last Updated: | March 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00305630 |
Health Authority: | United States: Food and Drug Administration |
Corticosteroids Triamcinolone Photodynamic therapy Choroidal neovascularization Age-related macular degeneration |
Macular degeneration Eye Diseases Choroid Diseases Macular Degeneration Retinal Degeneration Triamcinolone diacetate Choroidal Neovascularization |
Triamcinolone hexacetonide Triamcinolone Acetonide Metaplasia Triamcinolone Neovascularization, Pathologic Retinal Diseases Retinal degeneration |
Anti-Inflammatory Agents Uveal Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Glucocorticoids Hormones Immunosuppressive Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses |