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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uveal Melanoma | Drug: ranibizumab Drug: triamcinolone acetonide Other: sham | Phase 2 Phase 3 |
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 |

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 |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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;

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
Contact: Martine J Jager, MD, PhD | +31715263097 | m.j.jager@lumc.nl |
Principal Investigator: | Martine J Jager, MD, PhD | Leiden University Medical Center |
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 |
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 |
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 |