Study 12 of 2219 for search of: received on or after 11/14/2008
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Treatment Of Radiation Retinopathy Trial (TORR)
This study is enrolling participants by invitation only.
Sponsors and Collaborators: Leiden University Medical Center
Novartis Pharmaceuticals
Information provided by: Leiden University Medical Center 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
Uveal Melanoma
Drug: ranibizumab
Drug: triamcinolone acetonide
Other: sham
Phase II
Phase III

MedlinePlus related topics: Melanoma Retinal Disorders
Drug Information available for: Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide Ranibizumab BaseLine
U.S. FDA Resources
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.

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00811200

Sponsors and Collaborators
Leiden University Medical Center
Novartis Pharmaceuticals
Principal Investigator: Martine J Jager, MD, PhD Leiden University Medical Center
  More Information

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 Identifier: NCT00811200  
Health Authority: Netherlands: Dutch Health Care Inspectorate;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
triamcinolone acetonide
radiation retinopathy after irradiation of uveal melanoma
radiation maculopathy after irradiation of uveal melanoma
radiation choroidopathy after irradiation of uveal melanoma

Study placed in the following topic categories:
Eye Diseases
Choroid Diseases
Triamcinolone diacetate
Triamcinolone hexacetonide
Neuroendocrine Tumors
Melanoma of the choroid
Neuroectodermal Tumors
Uveal melanoma
Triamcinolone Acetonide
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Intraocular melanoma
Retinal Diseases

Additional relevant MeSH terms:
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
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Nevi and Melanomas processed this record on January 13, 2009