Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)
Phase 2
Completed
- Conditions
- Choroidal NeovascularizationAge-Related Macular Degeneration
- Registration Number
- NCT00305630
- Lead Sponsor
- Johns Hopkins University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
- Secondary Outcome Measures
Name Time Method Safety
Trial Locations
- Locations (2)
Johns Hopkins Univeristy School of Medicine
🇺🇸Baltimore, Maryland, United States
Oregon Health Science Univeristy
🇺🇸Portland, Oregon, United States