Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment Of Radiation Retinopathy Trial (TORR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Leiden University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00811200
First received: December 17, 2008
Last updated: June 30, 2009
Last verified: June 2009
  Purpose

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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


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: September 2009
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811200

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

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

No publications provided

Responsible Party: M.J. Jager, MD, Phd, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00811200     History of Changes
Other Study ID Numbers: P09.
Study First Received: December 17, 2008
Last Updated: June 30, 2009
Health Authority: Netherlands: Dutch Health Care Inspectorate
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Melanoma
Retinal Diseases
Eye Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014