Brief Title
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.
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 Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
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)
Secondary Outcome
To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment.
Condition
Uveal Melanoma
Intervention
ranibizumab
Study Arms / Comparison Groups
1: Lucentis
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
220
Start Date
September 2009
Primary Completion Date
January 2012
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;
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Martine J Jager, MD, PhD, +31715263097, [email protected]
Administrative Informations
NCT ID
NCT00811200
Organization ID
P09.
Study Sponsor
Leiden University Medical Center
Collaborators
Novartis Pharmaceuticals
Study Sponsor
Martine J Jager, MD, PhD, Principal Investigator, Leiden University Medical Center
Verification Date
June 2009