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NCT00943982 · ClinicalTrials.gov registry record · Phase 1
The Treatment of Uveitic Cystoid Macular Edema With Topical Interferon Gamma
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00943982 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT00943982, 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
Background: * Uveitis is a serious inflammatory condition that affects the eye and can cause vision loss. A common secondary problem associated with uveitis is macular edema (swelling). The macula is the part of the eye that is important for central vision, and swelling of the macula can lead to further vision loss. This condition is usually treated by medicines that target the immune system, but these medicines sometimes do not work or may cause side effects. * Interferon gamma-1b (Actimmune(Registered Trademark)) is a bioengineered protein that can alter the way inflammatory cells work in the immune system. Interferon gamma-1b is given as an intramuscular injection; however, this study will use the drug as an eye drop. This study represents the first time that interferon gamma-1b is given as an eye drop. Researchers hope that interferon gamma-1b will treat macular edema by decreasing the swelling in the back of the eye. Objectives: \- To investigate the safety and effectiveness of treating uveitis-associated macular edema with interferon gamma-1b. Eligibility: \- Individuals 18 years of age and older who have been diagnosed with macular edema associated with uveitis (in one or both eyes) for at least 3 months. Design: * Participants will have three planned clinic visits during this study over the course of 2 weeks. * All participants will have a medical history and eye examination. * When receiving the drops, participants will have optical coherence tomography (a detailed scan of the retina) 60 minutes and 30 minutes before the drops; upon receiving the drops; and 30, 60, and 120 minutes after receiving the drops. * After receiving the drops, participants will have another eye examination, blood drawn for samples, and further scans. * Participants will be asked to return to the NIH Clinical Center 1 week after receiving the drops for an evaluation....
Interventions
- DRUG Interferon Gamma 1-b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2009-07-17 |
| Est. Completion | 2010-06-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00943982
The ClinicalTrials.gov registry entry for NCT00943982 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 Interferon Gamma 1-b is the first listed.
NCT00943982 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00943982 about?
NCT00943982 is a clinical study titled "The Treatment of Uveitic Cystoid Macular Edema With Topical Interferon Gamma". Background: * Uveitis is a serious inflammatory condition that affects the eye and can cause vision loss. A common secondary problem associated with uveitis is macular edema (swelling). The macula is the part of the eye that is important for central vision, and swelling of the macula can lead to fu...
What is the current status of trial NCT00943982?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2009-07-17. Estimated completion is 2010-06-24.
What interventions are being tested in trial NCT00943982?
The interventions under investigation include: Interferon Gamma 1-b (DRUG).
Who is sponsoring clinical trial NCT00943982?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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