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

Primary Purpose

Choroidal Neovascularization, Age-Related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Periocular injection of triamcinolone acetonide 40mg

About this trial

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring Corticosteroids, Triamcinolone, Photodynamic therapy, Choroidal neovascularization, Age-related macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Johns Hopkins Univeristy School of Medicine
Oregon Health Science Univeristy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety

Full Information

NCT ID

NCT00305630

First Posted

March 20, 2006

Last Updated

March 20, 2006

Sponsor

Johns Hopkins University

Collaborators

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT00305630

Brief Title

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

Official Title

Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2006

Overall Recruitment Status

Completed

Study Start Date

July 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Johns Hopkins University

Collaborators

Oregon Health and Science University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Choroidal Neovascularization, Age-Related Macular Degeneration

Keywords

Corticosteroids, Triamcinolone, Photodynamic therapy, Choroidal neovascularization, Age-related macular degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Periocular injection of triamcinolone acetonide 40mg

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Safety

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas A Jabs, MD, MBA

Organizational Affiliation

Johns Hopkins University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Neil M Bressler, MD

Organizational Affiliation

Johns Hopkins Univeristy School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David J Wilson, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Univeristy School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Oregon Health Science Univeristy

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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