Uveal Melanoma
Conditions
Keywords
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
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.
Interventions
DRUGranibizumab
three initial monthly intra vitreal injections with 0.5 mg ranibizumab
DRUGtriamcinolone acetonide
at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide
OTHERsham
at baseline one sham-injection
Sponsors
Novartis Pharmaceuticals
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | one year |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment. | 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 | 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 | 4 weeks |
Contacts
Primary ContactMartine J Jager, MD, PhD
Outcome results
None listed