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

NCT ID: NCT00305630

Last Updated: 2006-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Choroidal Neovascularization Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Periocular injection of triamcinolone acetonide 40mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Principal Investigators

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Douglas A Jabs, MD, MBA

Role: STUDY_CHAIR

Johns Hopkins University

Neil M Bressler, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Univeristy School of Medicine

David J Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Johns Hopkins Univeristy School of Medicine

Baltimore, Maryland, United States

Site Status

Oregon Health Science Univeristy

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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IND 64263

Identifier Type: -

Identifier Source: org_study_id