Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema
Completed · Not applicable
Conditions studied: Melanoma
In brief
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.
Key facts
- Study ID
- NCT00441662
- Run by
- Wills Eye
- People needed
- 170
- Starts
- 2004-11-01
- Expected to finish
- 2007-05-01
- Last updated by the study team
- 2007-03-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Uveal melanoma new diagnosis, undergoing plaque radiation treatment
You may not qualify if…
- Pre-existing macular disease
- age-related macular degeneration
- diabetic maculopathy
- pre-existing retinal vascular occlusion
- macular hole
- surface wrinkling retinopathy
- prior retinal detachment
- media opacities precluding accurate OCT imaging
- known 'steroid responder'
- glaucoma
Where it is running
- Ocular Oncology Service, Wills Eye Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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