Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441662
Status:
COMPLETED
Last Update Posted:
2007-03-01
First Post:
2007-02-28
Brief Title:
Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema
Sponsor:
Wills Eye
Organization:
Wills Eye
Study Overview
Official Title:
Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema Following Plaque Radiotherapy for Uveal Melanoma
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None