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

This study has been completed.

First Received on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration 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

ClinicalTrials.gov Identifier:	NCT00305630 History of Changes
Other Study ID Numbers:	IND 64263
Study First Received:	March 20, 2006
Last Updated:	March 20, 2006
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:

Macular Degeneration
Neovascularization, Pathologic
Wet Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide

Triamcinolone
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012