Clinical trial NCT00811200: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Uveal Melanoma
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
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2008-12-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
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)
timeFrame: one year
Secondary outcomes:
measure: To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment.
timeFrame: one year
measure: 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
timeFrame: one year
measure: 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
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Leiden University Medical Center
name: Martine J Jager, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: