Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00056199 · ClinicalTrials.gov registry record · Phase 1
EYE001 to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome
A Phase 1 study of Hippel Lindau Disease, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00056199 is a Phase 1 study of Hippel Lindau Disease that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00056199, a Phase 1 study of Hippel Lindau Disease, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the ability of the experimental drug EYE001 to reduce retinal thickening and improve vision in patients with Von Hippel-Lindau syndrome (VHL). Angiomas (blood vessel tumors) commonly develop in the back of the eye on the retina and the optic nerve in patients with VHL. Although the 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. EYE001 decreases production of VEGF, a growth factor that is important for the formation of new blood vessels and that is elevated in VHL. Preliminary findings from studies of other retinal diseases suggest that EYE001 can reduce retinal thickening 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 will 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 will reveal 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. * Electroretinogram (ERG) to measure electrical responses generated from within the retina. For this test, the patient sits in a dark room for 30 minutes with his or her eyes patched. Then,
Conditions Studied
Interventions
- DRUG EYE001
Study Locations (1)
Maryland
- National Eye Institute (NEI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2003-03 |
| Est. Completion | 2005-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00056199
The ClinicalTrials.gov registry entry for NCT00056199 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 1 condition, with Hippel Lindau Disease appearing as the primary indexed condition, and to 1 intervention - of which EYE001 is the first listed.
NCT00056199 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00056199 about?
NCT00056199 is a clinical study titled "EYE001 to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome". This study will test the ability of the experimental drug EYE001 to reduce retinal thickening and improve vision in patients with Von Hippel-Lindau syndrome (VHL). Angiomas (blood vessel tumors) commonly develop in the back of the eye on the retina and the optic nerve in patients with VHL. Although ...
What is the current status of trial NCT00056199?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2003-03. Estimated completion is 2005-11.
What conditions does trial NCT00056199 study?
This clinical trial studies the following conditions: Hippel Lindau Disease.
What interventions are being tested in trial NCT00056199?
The interventions under investigation include: EYE001 (DRUG).
Who is sponsoring clinical trial NCT00056199?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00056199 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hippel Lindau Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.