Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma
Plaque radiotherapy is a commonly used method for treatment of small and medium-sized uveal
melanomas. Macular edema is one of the most common causes of visual loss after plaque
radiotherapy and has been reported in up to 70% of patients with posterior uveal melanoma.
Different methods have been proposed for treatment of post-radiation macular edema and
include periocular steroid, intravitreal steroid, intravitreal vascular endothelial growth
factor (VEGF) inhibitors, photodynamic therapy, and macular laser photocoagulation.
Injection of intravitreal triamcinolone (a form of steroid) has been found to be useful for
treatment of different forms of macular edema but is associated with considerable rates of
increased intraocular pressure (glaucoma). Dexamethasone is more potent than triamcinolone
and can be safely injected directly into the vitreous cavity (intravitreal injection) but
unfortunately its use in the form of intravitreal injection is not practical due to the
short half-life of intraocular dexamethasone (about 3 hours).
Within the past several years, tiny drug delivery systems have been developed that allow
sustained release of minute amounts of steroid into the back part (vitreous cavity) of the
eye, when they are implanted into the vitreous cavity. Ozurdex is a biodegradable
dexamethasone intravitreal implant that has been shown to be well-tolerated and effective
for up to 6 months in reducing vision loss and improving visual outcome in eyes with
different types of macular edema including those secondary to diabetic retinopathy and
retinal vein occlusion.
In this study the investigators would like to evaluate the safety and effectiveness of
Ozurdex (dexamethasone intravitreal implant) for treatment of macular edema developing after
plaque radiotherapy of uveal melanoma.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of eyes showing >=2 lines of improvement in best-corrected visual acuity
At 12 months
United States: Food and Drug Administration
Wills IRB# 11-089
|Ocular Oncology Service, Wills Eye Institute||Philadelphia, Pennsylvania 19107|