Uveal Melanoma | Treatment Of Radiation Retinopathy Trial
Uveal Melanoma research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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;
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:ranibizumabthree initial monthly intra vitreal injections with 0.5 mg ranibizumab
Drug:triamcinolone acetonideat baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide
Other:shamat baseline one sham-injection
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
3: No treatment
Start Date: September 2009
Phase: Phase 2/Phase 3
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.
Study sponsors, principal investigator, and references
Principal Investigator: Martine J Jager, MD, PhD
Lead Sponsor: Leiden University Medical Center
Collaborator: Novartis Pharmaceuticals