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

This study has been completed.
Sponsor:
Information provided by:
Wills Eye
ClinicalTrials.gov Identifier:
NCT00441662
First received: February 28, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Melanoma
Drug: Sub-Tenon triamcinolone 40mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema Following Plaque Radiotherapy for Uveal Melanoma

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Presence of macular edema on optical coherence tomography

Secondary Outcome Measures:
  • Grade of macular edema on optical coherence tomography
  • Foveal thickness measurement by optical coherence tomography
  • Visual acuity

Estimated Enrollment: 170
Study Start Date: November 2004
Estimated Study Completion Date: May 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441662

Locations
United States, Pennsylvania
Ocular Oncology Service, Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Investigators
Principal Investigator: Carol L Shields, M.D. Ocular Oncology Service, Wills Eye Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00441662     History of Changes
Other Study ID Numbers: Wills Eye Sub-Tenon Kenalog
Study First Received: February 28, 2007
Last Updated: February 28, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
Melanoma
Uvea
Macula
Edema
Plaque radiotherapy
Brachytherapy
Triamcinolone

Additional relevant MeSH terms:
Macular Edema
Melanoma
Eye Diseases
Macular Degeneration
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Retinal Degeneration
Retinal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014