Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma
This is a Phase I clinical trial to test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy following plaque brachytherapy for patients with choroidal melanoma using the incidence and severity of events criteria.
The secondary objective is to assess the efficacy of intravitreal ranibizumab on regression of radiation retinopathy by ophthalmic examination, fundus photography, fluorescein angiography, and optical coherence tomography, as well as visual acuity.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study to Evaluate the Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma|
- To test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy associated with plaque brachytherapy for choroidal melanoma [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To assess the efficacy of intravitreal ranibizumab on treating radiation retinopathy following plaque brachytherapy for choroidal melanoma, and effect on visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Intravitreal ranibizumab
Patients will receive intravitreal ranibizumab on a monthly basis depending on response to treatment
intravitreal ranibizumab monthly for 4 months, and then every month thereafter until month 12.
Other Name: LucentisDrug: ranibizumab
intravitreal ranibizumab 0.5 mg
Other Name: Lucentis
Following plaque brachytherapy as treatment for choroidal melanoma, patients may develop radiation retinopathy. Radiation retinopathy is a progressive condition that leads to blindness in over 50% of cases within 5 years of treatment.
Vascular endothelial growth factor (VEGF) protein is believed to play a critical role in angiogenesis and radiation retinopathy. It is one of the key contributors to physiological or pathological conditions that can stimulate both the formation of new blood vessels and normal vessel incompetence. Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown to be effective in treating exudative macular degeneration. Ranibizumab binds to and inhibits vascular endothelial growth factor A (VEGF-A), which has been shown to cause neovascularization and leakage in models of ocular angiogenesis.
This is an open label, non-randomized active treatment, Phase I trial to assess the safety and tolerability of intravitreal ranibizumab and its ability to reduce radiation retinopathy and potentially limit vision loss associated with this disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750399
|United States, New York|
|The New York Eye Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Paul T Finger, MD||The New York Eye Cancer Center|