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NCT00081835 · ClinicalTrials.gov registry record · Phase 2
Evaluation and Treatment of Eye Complications of Vaccinia Vaccination
A Phase 2 study of Vaccinia, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT00081835 is a Phase 2 study of Vaccinia that has completed, run by National Eye Institute (NEI). The registered enrollment target is 400 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00081835, a Phase 2 study of Vaccinia, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate patients with eye complications related to vaccination against smallpox to learn more about these conditions. Vaccinia vaccination has been used for more than 100 years for preventing smallpox. A small number of people who receive the vaccination (less than 1 in 1,000) develop complications, sometimes in their eyes. This usually results from the accidental transfer of the infection from the vaccination site to the face or eyes, perhaps by touching the vaccination area and then the face or eyelids before washing the hands. The study will also examine whether an experimental treatment called NP-016 vaccinia immune globulin can reduce corneal scarring that is sometimes associated with serious vaccinia complications and can impair vision. Children and adults with keratitis, severe conjunctivitis, or blepharitis following exposure to vaccinia vaccination may be eligible for this study. Children must weigh at least 10 kg. Participants undergo the following tests and procedures at enrollment, with some tests repeated at scheduled study visits: 1. Medical history and physical examination 2. Infectious disease consultation 3. Complete eye evaluation including: * Fundus photography to examine the back of the eye - dilation of the pupils with eye drops to examine and photograph the back of the eye * Slit lamp biomicroscopy - evaluation of the front part of the eye with a slit lamp microscope * Eye pressure measurements * Eye swab to look for vaccinia virus or other causes of disease 4. Blood tests 5. Photographs and documentation of eye and skin lesions 6. Vaccinia diagnostic tests, such as skin or mucosa scrapings; blood, throat, or urine cultures; and tissue biopsies, if needed Patients begin treatment with standard medications for their eye disease, such as trifluridine (Viroptic® (Registered Trademark)) anti-viral eye drops. Patients whose condition becomes serious are offered additional treatment with intravenous (through a vein)
Conditions Studied
Interventions
- DRUG NP-016 Vaccine Immune Globulin (IV-VIG)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2004-04-19 |
| Est. Completion | 2007-08-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00081835
The ClinicalTrials.gov registry entry for NCT00081835 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 400 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 Vaccinia appearing as the primary indexed condition, and to 1 intervention - of which NP-016 Vaccine Immune Globulin (IV-VIG) is the first listed.
NCT00081835 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00081835 about?
NCT00081835 is a clinical study titled "Evaluation and Treatment of Eye Complications of Vaccinia Vaccination". This study will evaluate patients with eye complications related to vaccination against smallpox to learn more about these conditions. Vaccinia vaccination has been used for more than 100 years for preventing smallpox. A small number of people who receive the vaccination (less than 1 in 1,000) devel...
What is the current status of trial NCT00081835?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2004-04-19. Estimated completion is 2007-08-15.
What conditions does trial NCT00081835 study?
This clinical trial studies the following conditions: Vaccinia.
What interventions are being tested in trial NCT00081835?
The interventions under investigation include: NP-016 Vaccine Immune Globulin (IV-VIG) (DRUG).
Who is sponsoring clinical trial NCT00081835?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00081835 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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