A Phase 4 interventional study of Ranibizumab in Uveal Melanoma, Radiation Retinopathy and Radiation Maculopathy, sponsored by Shields, Shields and Associates. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-10-08.
Sponsored by Shields, Shields and Associates · Phase 4, Interventional, and Prevention
Uveal Melanoma is the most common primary intraocular malignancy in adulthood. Eye preserving treatments can deliver equivalent life prognosis in the management of small and medium sized uveal melanomas, as compared to enucleation. Plaque radiotherapy has emerged as the most common eye-preserving treatment in the current management of uveal melanoma, but is complicated by visual loss in approximately 70% of patients at 10 years follow-up. Strategies for the prevention and early treatment of radiation retinopathy/maculopathy need to be developed to improve visual outcomes following plaque treatment. Ranibizumab (Lucentis) is the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits the activity of vascular endothelial growth factor A, a mediator in the development of choroidal neovascularization. Lucentis is commonly used in the eye for eye conditions such as age related macular degeneration. This study will investigate the possible benefit of Anti-VEGF therapy (Lucentis) in reducing the incidence of radiation complications following plaque radiation for uveal melanoma.
3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's planned enrollment of 400 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.
Browse Melanoma studies →This is the only study on the registry with Shields, Shields and Associates as lead sponsor.
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Exclusion Criteria:
Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion
Also known as: Lucentis
Presence or absence of optical coherence (OCT) evidence of macular edema.
Time frame: 4 months
Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up.
Time frame: 4 months
This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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