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Clinical Trial Summary

This open-label study will pilot the use of systemic sunitinib malate, a dual inhibitor of vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF), in five participants with Von Hippel-Lindau (VHL) to investigate its potential efficacy as a treatment for retinal angiomas. Participants will have visual dysfunction with either visual acuity loss or visual field loss from retinal angiomas secondary to genetically confirmed VHL. This open-label study will pilot the use of systemic sunitinib malate in five participants to investigate its potential efficacy as a treatment for retinal angiomas associated with VHL. Participants will receive nine months of sunitinib malate therapy (six cycles total - one cycle consists of 50 mg oral dose once daily for four weeks followed by a two week rest period). The primary outcome will be a change in the best-corrected visual acuity of more than or equal to 15 letters from baseline to the Week 36 visit. The secondary ocular outcomes will focus on retinal thickness and leakage of the retinal angioma at the Week 36 visit. Optical coherence tomography will document changes in retinal thickening and fluorescein angiography will be used to determine leakage of the retinal angioma.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT00673816
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date May 2008
Completion date February 2011

See also
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Terminated NCT00330564 - Evaluation of Sunitinib Malate in Patients With Von Hippel-Lindau Syndrome (VHL) Who Have VHL Lesions to Follow Phase 2
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Recruiting NCT01496625 - National Eye Institute Biorepository for Retinal Diseases
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Completed NCT01436227 - Pazopanib Hydrochloride in Treating Patients With Von Hippel-Lindau Syndrome Phase 2
Completed NCT00075348 - Genetic Study to Identify Gene Mutations in Participants Previously Enrolled in Clinical Trial NCI-99-C-0053 Who Have Von Hippel-Lindau Syndrome or Are at Risk for Von Hippel-Lindau Syndrome N/A
Completed NCT00089765 - Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome Phase 1