Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.
Approximately 30-40% of patients develop a deterioration of visual acuity within 5 years
after treatment of uveal melanoma using radiation therapy and TTT due to radiation
retinopathy (Shields 2002, Bartlema 2003). By administration of either Lucentis® or
Triamcinolone® we hope to treat complications of radiation therapy, by demonstrating a
statistically significant improvement in visual acuity and a reduced amount of macular edema
and vascular leakage. Additionally, we hope to obtain a better understanding of the
pathophysiologic processes involved, by demonstrating a possible relation between high
levels of angiogenic factors (VEGF) in the anterior chamber fluid, and radiation
retinopathy. In conclusion, we hope to provide evidence for a new therapy in patients with
retinopathy, due to radiation in uveal melanoma. There is no scientifically proven treatment
available at this time.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
To demonstrate a statistically significant superiority of intravitreal ranibizumab (0.5mg) or triamcinolone acetonide (4.0mg) to no treatment, in the mean change from baseline in best corrected visual acuity (BCVA)
one year
No
Martine J Jager, MD, PhD
Principal Investigator
Leiden University Medical Center
Netherlands: Dutch Health Care Inspectorate
P09.
NCT00811200
September 2009
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