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

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00305630

Collaborator

Oregon Health and Science University (Other)

100

Enrollment

Locations

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jul 1, 2002

Study Completion Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization. []

Secondary Outcome Measures

Safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Univeristy School of Medicine	Baltimore	Maryland	United States	21287
2	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