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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441662
• Other study ID #: Wills Eye Sub-Tenon Kenalog
• Status: Completed
• Phase: N/A
• First received: February 28, 2007
• Last updated: February 28, 2007
• Start date: November 2004
• Est. completion date: May 2007

Study information

• Verified date: February 2007
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Macular Edema
• Melanoma

Intervention

Drug:
• Sub-Tenon triamcinolone 40mg

Locations

Country	Name	City	State
United States	Ocular Oncology Service, Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

References & Publications (3)

Shields CL, Cater J, Shields JA, Chao A, Krema H, Materin M, Brady LW. Combined plaque radiotherapy and transpupillary thermotherapy for choroidal melanoma: tumor control and treatment complications in 270 consecutive patients. Arch Ophthalmol. 2002 Jul;120(7):933-40. — View Citation

Shields CL, Shields JA, Cater J, Gündüz K, Miyamoto C, Micaily B, Brady LW. Plaque radiotherapy for uveal melanoma: long-term visual outcome in 1106 consecutive patients. Arch Ophthalmol. 2000 Sep;118(9):1219-28. — View Citation

Shields CL, Shields JA, Gündüz K, Freire JE, Mercado G. Radiation therapy for uveal malignant melanoma. Ophthalmic Surg Lasers. 1998 May;29(5):397-409. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of macular edema on optical coherence tomography
Secondary	Grade of macular edema on optical coherence tomography
Secondary	Foveal thickness measurement by optical coherence tomography
Secondary	Visual acuity

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