Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.
18 Years
N/A
Both
Uveal Melanoma
Trial Information
Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.
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.
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;
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
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)
Outcome Time Frame:
one year
Safety Issue:
No
Principal Investigator
Martine J Jager, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Leiden University Medical Center
Authority:
Netherlands: Dutch Health Care Inspectorate
Study ID:
P09.
NCT ID:
NCT00811200
Start Date:
September 2009
Completion Date:
Related Keywords:
- Uveal Melanoma
- 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
- Uveal Neoplasms
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