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Completed

NCT Number: NCT00441662

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

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.

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Key information

Conditions

Melanoma Edema Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ocular Oncology Service, Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

About this study

BACKGROUND: Uveal melanoma is the most common primary intraocular malignancy. Plaque radiation (brachytherapy) has emerged as the most common treatment in the current management of uveal melanoma, but is complicated by visual loss in close to 70% of patients at 10 years follow-up. Strategies for the prevention and early treatment of radiation retinopathy (and radiation maculopathy in particular) need to be developed to improve visual outcome following eye-conserving treatment of uveal melanoma. Triamcinolone, a long acting locally-administered corticosteroid, is of established benefit in macular oedema from other causes.

PURPOSE: This study will evaluate the efficacy of sub-Tenon triamcinolone in the prevention of radiation maculopathy in patients undergoing plaque radiotherapy for uveal melanoma.

DESIGN: A prospective randomised control study.

STUDY POPULATION: 170 patients undergoing plaque radiation treatment for uveal melanoma.

SETTING: Ocular Oncology Service, Wills Eye Hospital, Philadelphia, USA.

INTERVENTION: Triamcinolone acetonide (40 mg in 1 cc) injected into the sub-Tenon space using sterile technique at the time of plaque radiotherapy and 4 and 8 months later.

OUTCOME MEASURES: Visual acuity, optical coherence tomographic (OCT) analysis of macular architecture and foveal thickness, at 4, 8, and 12 months following brachytherapy.

Exclusion criteria

Pre-existing macular disease (e.g. age-related macular degeneration, diabetic maculopathy, vascular occlusion, macular hole); prior retinal detachment; media opacities precluding accurate OCT imaging; history of intraocular pressure elevation related to corticosteroid treatment -'steroid responder'; history of glaucoma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sub-Tenon triamcinolone 40mg

Drug

Primary outcomes

  1. Presence of macular edema on optical coherence tomography

Secondary outcomes

  1. Grade of macular edema on optical coherence tomography

  2. Foveal thickness measurement by optical coherence tomography

  3. Visual acuity

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Official study title

Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema Following Plaque Radiotherapy for Uveal Melanoma

Important dates

Study start
2004
Study completion
2007
First posted
Mar 1, 2007
Registry last updated
Mar 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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