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

This study has been completed.

First Received: March 20, 2006 No Changes Posted

Sponsor:	Johns Hopkins University
Collaborator:	Oregon Health and Science University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00305630

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide Corticosteroids

U.S. FDA Resources

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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	IND 64263
Study First Received:	March 20, 2006
Last Updated:	March 20, 2006
ClinicalTrials.gov Identifier:	NCT00305630 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

Corticosteroids
Triamcinolone
Photodynamic therapy
Choroidal neovascularization
Age-related macular degeneration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Triamcinolone hexacetonide
Triamcinolone Acetonide
Pathologic Processes
Metaplasia
Therapeutic Uses
Triamcinolone
Retinal Diseases

Uveal Diseases
Eye Diseases
Choroid Diseases
Retinal Degeneration
Macular Degeneration
Triamcinolone diacetate
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Choroidal Neovascularization
Neovascularization, Pathologic

ClinicalTrials.gov processed this record on February 08, 2010