drugset / Trial / NCT00441662

Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema

NCT00441662

Completed 170 enrolled Wills Eye
RandomizedParallel-groupOpen-labelPrevention

Summary

Melanoma is the most common primary tumour which occurs inside the eye. For over 20-years, it has been possible, in many cases, to use local delivery of radiation to the eye to treat this type of tumour, avoiding the need to surgically remove the affected eye. This treatment, however, is often complicated by radiation-induced loss of vision, months or years after treatment. The aim of this research project is to investigate the potential prevention of radiation complications in the eye by giving anti-inflammatory medication (a long-acting steroid) in the form of a local injection around the eye at the time of treatment, and at 4-months and 8-months following treatment. This medication (named 'triamcinolone') has been successfully used to treat similar complications of diabetic eye disease, for example, and has a good safety profile. The rationale of this study is to attempt to preserve vision, in addition to preserving the eye, in patients affected by this eye tumour, and therefore preserve quality of life for these patients.

Timeline

Start
2004-11
Primary completion
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Triamcinolone Other / unclassified 40 mg Other

Indications