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Treatment Of Radiation Retinopathy Trial (TORR)

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ClinicalTrials.gov Identifier: NCT00811200
Recruitment Status : Unknown
Verified June 2009 by Leiden University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 18, 2008
Last Update Posted : July 2, 2009
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Leiden University Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Uveal Melanoma Drug: ranibizumab Drug: triamcinolone acetonide Other: sham Phase 2 Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Study Start Date : September 2009
Estimated Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1: Lucentis Drug: ranibizumab
three initial monthly intra vitreal injections with 0.5 mg ranibizumab
Active Comparator: 2: Kenalog Drug: triamcinolone acetonide
at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide
Sham Comparator: 3: No treatment Other: sham
at baseline one sham-injection


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment. [ Time Frame: one year ]
  2. To evaluate the effects of ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) on central retinal thickness, severity of retinopathy and other anatomical changes relative to no treatment [ Time Frame: one year ]
  3. To demonstrate a possible relation between decreasing levels of angiogenic factors (such as VEGF) in the anterior chamber fluid and a good response to treatment with ranibizumab or triamcinolone acetonide, and radiation retinopathy [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The eye was previously irradiated for treatment of a uveal melanoma;
  • Decrease of visual acuity after irradiation therapy by more than 10 letters (ETDRS) and is now 20/40 or less;
  • Vision decrease is considered to be due to central radiation retinopathy with significant macular edema or optic disc edema;
  • Age 18 years or older;
  • The patient is fully competent;
  • Written informed consent to participate in the trial is given.
  • Patient is not pregnant (or not fertile) and is willing to use contraceptives for the duration of the trial (one year)
  • Patient is willing and able to return for follow-up.

Exclusion Criteria:

  • Vision decrease is considered to be due to ischemic radiation retinopathy without macular edema or optic disc edema;
  • Other, approved therapy indicated for treatment of condition;
  • Presence of metastasis;
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial;
  • Pre-existing retinopathy due to other disorders;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811200


Contacts
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Contact: Martine J Jager, MD, PhD +31715263097 m.j.jager@lumc.nl

Sponsors and Collaborators
Leiden University Medical Center
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Martine J Jager, MD, PhD Leiden University Medical Center
More Information
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Responsible Party: M.J. Jager, MD, Phd, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00811200    
Other Study ID Numbers: P09.
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: June 2009
Keywords provided by Leiden University Medical Center:
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
Additional relevant MeSH terms:
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Melanoma
Retinal Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Ranibizumab
Triamcinolone diacetate
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action