NCT Number: NCT00305630
Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)
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.
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Conditions
Age range
50 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Johns Hopkins Univeristy School of Medicine, Baltimore, Maryland, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
Secondary outcomes
-
Safety
Sponsors and collaborators
Lead sponsor
Johns Hopkins University
Other
Collaborators
- Oregon Health and Science University
Registry information
Official study title
Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy
Important dates
- Study start
- 2002
- Study completion
- 2005
- First posted
- Mar 22, 2006
- Registry last updated
- Mar 22, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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