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Treatment Of Radiation Retinopathy Trial (TORR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 17, 2008
First Posted Date  ICMJE December 18, 2008
Last Update Posted Date July 2, 2009
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2008)
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment Of Radiation Retinopathy Trial
Official Title  ICMJE Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Uveal Melanoma
Intervention  ICMJE
  • Drug: ranibizumab
    three initial monthly intra vitreal injections with 0.5 mg ranibizumab
  • Drug: triamcinolone acetonide
    at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide
  • Other: sham
    at baseline one sham-injection
Study Arms  ICMJE
  • Active Comparator: 1: Lucentis
    Intervention: Drug: ranibizumab
  • Active Comparator: 2: Kenalog
    Intervention: Drug: triamcinolone acetonide
  • Sham Comparator: 3: No treatment
    Intervention: Other: sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 17, 2008)
220
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00811200
Other Study ID Numbers  ICMJE P09.
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.J. Jager, MD, Phd, Leiden University Medical Center
Study Sponsor  ICMJE Leiden University Medical Center
Collaborators  ICMJE Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Martine J Jager, MD, PhD Leiden University Medical Center
PRS Account Leiden University Medical Center
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP