Treatment Of Radiation Retinopathy Trial

Leiden University Medical Center220 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

220

Conditions

Uveal Melanoma

Interventions

ranibizumabDRUG

three initial monthly intra vitreal injections with 0.5 mg ranibizumab

triamcinolone acetonideDRUG

at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide

shamOTHER

at baseline one sham-injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Martine J Jager, MD, PhD

CONTACT

+31715263097 m.j.jager@lumc.nl

Data from ClinicalTrials.gov

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