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NCT00673816 · ClinicalTrials.gov registry record · Phase 1
Sunitinib Malate to Treat Advanced Eye Disease in Patients With Von Hippel-Lindau Syndrome
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT00673816 is a Phase 1 study that was terminated before completion, run by National Eye Institute (NEI). The registered enrollment target is 2 participants.
The verdict
NCT00673816, a Phase 1 study, was terminated before completion, sponsored by National Eye Institute (NEI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- DRUG Sunitinib Malate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2008-05 |
| Est. Completion | 2011-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00673816
The ClinicalTrials.gov registry entry for NCT00673816 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sunitinib Malate is the first listed.
NCT00673816 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00673816 about?
NCT00673816 is a clinical study titled "Sunitinib Malate to Treat Advanced Eye Disease in Patients With Von Hippel-Lindau Syndrome". 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....
What is the current status of trial NCT00673816?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2008-05. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00673816?
The interventions under investigation include: Sunitinib Malate (DRUG).
Who is sponsoring clinical trial NCT00673816?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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