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

March 20, 2006
March 20, 2006
July 2002
Not Provided
Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
Same as current
No Changes Posted
Safety
Same as current
Not Provided
Not Provided
 
Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)
Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Choroidal Neovascularization
  • Age-Related Macular Degeneration
Drug: Periocular injection of triamcinolone acetonide 40mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2005
Not Provided

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00305630
IND 64263
Not Provided
Not Provided
Johns Hopkins University
Oregon Health and Science University
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
Johns Hopkins University
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP