Treatment Of Radiation Retinopathy Trial

Phase 2

• Conditions: Uveal Melanoma
• Interventions: Drug: ranibizumab; Other: sham; Drug: triamcinolone acetonide

• Registration Number: NCT00811200
• Lead Sponsor: Leiden University Medical Center

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.

Study Timeline

• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-30
• Last Update Posted: 2009-07-02
• Study Start: 2009-09
• Primary Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Lucentis	ranibizumab	-
3: No treatment	sham	-
2: Kenalog	triamcinolone acetonide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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