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NCT00089765 · ClinicalTrials.gov registry record · Phase 1
Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00089765 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT00089765, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study will examine whether he drug ranibizumab can slow or stop the growth of angiomas (blood vessel tumors) in patients with Von Hippel-Lindau syndrome (VHL). Angiomas commonly develop in the back of the eye on the retina and the optic nerve in patients with VHL. Although these tumors are not cancerous, they may cause significant vision loss. Current treatments, including laser therapy, cryotherapy, and vitrectomy, may not be successful or possible for all patients. Ranibizumab decreases production of VEGF, a growth factor that is important for the formation of new blood vessels and that is elevated in patients with VHL. Preliminary findings from other studies suggest that ranibizumab can reduce retinal thickening caused by vessel and tumor growth and improve vision. Patients 18 years of age and older with retinal angiomas due to VHL in one or both eyes and central vision loss of 20/40 or worse may be eligible for this study. Participants undergo the following tests and procedures: * Medical history, physical examination, electrocardiogram (EKG) and blood tests. * Eye examination, including eye pressure measurement and dilation of the pupils to examine the retina. * Fluorescein angiography to evaluate the eye's blood vessels. For this test, a yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. * Optical coherence tomography to measure retinal thickness. The eyes are examined through a machine that produces cross-sectional pictures of the retina. These measures are repeated during the study to determine changes, if any, in retinal thickening. * Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to examine and photograph the back of the eye. * Electroretinogram (ERG)
Interventions
- DRUG Ranibizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2004-08-10 |
| Est. Completion | 2007-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00089765
The ClinicalTrials.gov registry entry for NCT00089765 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 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 Ranibizumab is the first listed.
NCT00089765 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00089765 about?
NCT00089765 is a clinical study titled "Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome". This study will examine whether he drug ranibizumab can slow or stop the growth of angiomas (blood vessel tumors) in patients with Von Hippel-Lindau syndrome (VHL). Angiomas commonly develop in the back of the eye on the retina and the optic nerve in patients with VHL. Although these tumors are not ...
What is the current status of trial NCT00089765?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2004-08-10. Estimated completion is 2007-08-15.
What interventions are being tested in trial NCT00089765?
The interventions under investigation include: Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT00089765?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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