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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: Clinical Trial Phase 1 study, sponsored by National Eye Institute (NEI).
NCT00673816 is a Phase 1 study that was terminated before completion, run by National Eye Institute (NEI). The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Interventions
- DRUG Sunitinib Malate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2008-05 |
| Est. Completion | 2011-02 |
| Phase | Phase 1 |
Why NCT00673816 stopped before completion
NCT00673816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Sunitinib Malate is the first listed.
NCT00673816 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00673816's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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