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

NCT00441662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2007-03-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sub-Tenon triamcinolone 40mg

Sponsors & Collaborators

  • Wills Eye

    lead OTHER

Principal Investigators

  • Carol L Shields, M.D. · Ocular Oncology Service, Wills Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Completion
2007-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00441662 on ClinicalTrials.gov