Age-Related Macular Degeneration, Choroidal Neovascularization
Conditions
Keywords
Corticosteroids, Triamcinolone, Photodynamic therapy, Choroidal neovascularization, Age-related macular degeneration
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.
Interventions
DRUGPeriocular injection of triamcinolone acetonide 40mg
Sponsors
Oregon Health and Science University
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
United States
Outcome results
None listed