Treatment Of Radiation Retinopathy Trial
Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.
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.
Phase 2/Phase 3
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)
To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment.
Study Arms / Comparison Groups
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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;
18 Years - N/A
Accepts Healthy Volunteers
Martine J Jager, MD, PhD, +31715263097, [email protected]
Leiden University Medical Center
Martine J Jager, MD, PhD, Principal Investigator, Leiden University Medical Center