Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema Following Plaque Radiotherapy for Uveal Melanoma
BACKGROUND: Uveal melanoma is the most common primary intraocular malignancy. Plaque
radiation (brachytherapy) has emerged as the most common treatment in the current management
of uveal melanoma, but is complicated by visual loss in close to 70% of patients at 10 years
follow-up. Strategies for the prevention and early treatment of radiation retinopathy (and
radiation maculopathy in particular) need to be developed to improve visual outcome
following eye-conserving treatment of uveal melanoma. Triamcinolone, a long acting
locally-administered corticosteroid, is of established benefit in macular oedema from other
PURPOSE: This study will evaluate the efficacy of sub-Tenon triamcinolone in the prevention
of radiation maculopathy in patients undergoing plaque radiotherapy for uveal melanoma.
DESIGN: A prospective randomised control study.
STUDY POPULATION: 170 patients undergoing plaque radiation treatment for uveal melanoma.
SETTING: Ocular Oncology Service, Wills Eye Hospital, Philadelphia, USA.
INTERVENTION: Triamcinolone acetonide (40 mg in 1 cc) injected into the sub-Tenon space
using sterile technique at the time of plaque radiotherapy and 4 and 8 months later.
OUTCOME MEASURES: Visual acuity, optical coherence tomographic (OCT) analysis of macular
architecture and foveal thickness, at 4, 8, and 12 months following brachytherapy.
EXCLUSION CRITERIA: Pre-existing macular disease (e.g. age-related macular degeneration,
diabetic maculopathy, vascular occlusion, macular hole); prior retinal detachment; media
opacities precluding accurate OCT imaging; history of intraocular pressure elevation related
to corticosteroid treatment -'steroid responder'; history of glaucoma.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Presence of macular edema on optical coherence tomography
Carol L Shields, M.D.
Ocular Oncology Service, Wills Eye Institute
United States: Institutional Review Board
Wills Eye Sub-Tenon Kenalog
|Ocular Oncology Service, Wills Eye Institute||Philadelphia, Pennsylvania 19107|