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

This study has been completed.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00305630
First received: March 20, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  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 2
Phase 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Choroidal Neovascularization
Wet Macular Degeneration
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 September 30, 2014