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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: Completed Phase 1 study of Hippel Lindau Disease, sponsored by National Eye Institute (NEI).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00056199 record still lists
NCT00056199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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
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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.
Where NCT00056199's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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