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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 Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma. |
Estimated Enrollment: | 220 |
Study Start Date: | September 2009 |
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:
Contact: Martine J Jager, MD, PhD | +31715263097 | m.j.jager@lumc.nl |
Principal Investigator: | Martine J Jager, MD, PhD | Leiden University Medical Center |
Responsible Party: | Leiden University Medical Center ( M.J. Jager, MD, Phd ) |
Study ID Numbers: | P09. |
Study First Received: | December 17, 2008 |
Last Updated: | June 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00811200 History of Changes |
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 |
Anti-Inflammatory Agents Immunologic Factors Uveal Melanoma Hormone Antagonists Eye Diseases Choroid Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Melanoma of the Choroid Triamcinolone diacetate Immunosuppressive Agents Hormones Glucocorticoids |
Triamcinolone hexacetonide Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Triamcinolone Acetonide Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Triamcinolone Intraocular Melanoma Neuroepithelioma Nevus Retinal Diseases |
Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Neoplasms, Nerve Tissue Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Triamcinolone hexacetonide Melanoma Triamcinolone Acetonide Neoplasms, Germ Cell and Embryonal Therapeutic Uses Triamcinolone |
Nevi and Melanomas Retinal Diseases Neoplasms by Histologic Type Eye Diseases Triamcinolone diacetate Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms |