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


N/A
18 Years
N/A
Not Enrolling
Both
Melanoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Presence of macular edema on optical coherence tomography

Principal Investigator

Carol L Shields, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ocular Oncology Service, Wills Eye Institute

Authority:

United States: Institutional Review Board

Study ID:

Wills Eye Sub-Tenon Kenalog

NCT ID:

NCT00441662

Start Date:

November 2004

Completion Date:

May 2007

Related Keywords:

  • Melanoma
  • Melanoma
  • Uvea
  • Macula
  • Edema
  • Plaque radiotherapy
  • Brachytherapy
  • Triamcinolone
  • Edema
  • Macular Edema
  • Melanoma

Name

Location

Ocular Oncology Service, Wills Eye InstitutePhiladelphia, Pennsylvania  19107