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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wills Eye
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Uveal melanoma new diagnosis, undergoing plaque radiation treatment

Exclusion Criteria:

• 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