Choroidal Melanoma Clinical Trial
Official title:
An Open Label Study to Evaluate the 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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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