Treatment Of Radiation Retinopathy Trial (TORR)

• ClinicalTrials.gov Identifier: NCT00811200
• Recruitment Status: Unknown
• First Posted: December 18, 2008
• Last Update Posted: July 2, 2009
• Sponsor: Leiden University Medical Center
• Collaborator: Novartis Pharmaceuticals
• Information provided by: Leiden University Medical Center

Tracking Information

• First Submitted Date: December 17, 2008
• First Posted Date: December 18, 2008
• Last Update Posted Date: July 2, 2009
• Study Start Date: September 2009
• Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment Of Radiation Retinopathy Trial
• 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.
• 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Uveal Melanoma

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 17, 2008): 220
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility 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;

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00811200
• Other Study ID Numbers: P09.
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: M.J. Jager, MD, Phd, Leiden University Medical Center
• Study Sponsor: Leiden University Medical Center
• Collaborators: Novartis Pharmaceuticals

Investigators

• Principal Investigator: Martine J Jager, MD, PhD; Leiden University Medical Center

• PRS Account: Leiden University Medical Center
• Verification Date: June 2009