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Sponsors and Collaborators: |
Leiden University Medical Center Novartis Pharmaceuticals |
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Information provided by: | Leiden University Medical Center |
ClinicalTrials.gov Identifier: | NCT00811200 |
The purpose of this study is to demonstrate a statistically significant improvement of visual acuity after treatment using either Lucentis® or Triamcinolone® compared to no treatment, in patients with radiation retinopathy.
Condition | Intervention | Phase |
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Uveal Melanoma |
Drug: ranibizumab Drug: triamcinolone acetonide Other: sham |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma. |
Estimated Enrollment: | 220 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Lucentis: Active Comparator |
Drug: ranibizumab
three initial monthly intra vitreal injections with 0.5 mg ranibizumab
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2: Kenalog: Active Comparator |
Drug: triamcinolone acetonide
at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide
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3: No treatment: Sham Comparator |
Other: sham
at baseline one sham-injection
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Leiden University Medical Center ( M.J. Jager, MD, Phd ) |
Study ID Numbers: | P07.070 |
Study First Received: | December 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00811200 |
Health Authority: | Netherlands: Dutch Health Care Inspectorate; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
radiation retinopathy maculopathy choroidopathy uveal melanoma lucentis |
ranibizumab kenalog triamcinolone acetonide radiation retinopathy after irradiation of uveal melanoma radiation maculopathy after irradiation of uveal melanoma radiation choroidopathy after irradiation of uveal melanoma |
Eye Diseases Choroid Diseases Triamcinolone diacetate Triamcinolone hexacetonide Melanoma Neuroendocrine Tumors Melanoma of the choroid Neuroectodermal Tumors Uveal melanoma |
Triamcinolone Acetonide Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular melanoma Triamcinolone Neuroepithelioma Nevus Retinal Diseases |
Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Neoplasms, Nerve Tissue Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Glucocorticoids Hormones Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Nevi and Melanomas |