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NCT01468337 · ClinicalTrials.gov registry record · Phase 1
Topical Interferon Gamma-1b for Central Serous Chorioretinopathy
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01468337 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT01468337, 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: \- In the eye disease central serous chorioretinopathy (CSC), fluid collects under the retina at the back of the eye. CSC can resolve on its own, but in some people it lasts for several months or can come back. The fluid buildup during CSC can cause vision loss. The drug interferon gamma-1b can help reduce fluid accumulation in the retina. Researchers want to see if interferon gamma-1b can help treat and prevent vision loss from CSC. Objectives: \- To see if interferon gamma-1b eye drops are a safe and effective treatment for CSC. Eligibility: \- Individuals at least 18 years of age who have CSC in at least one eye. Design: * Participants will be screened with a physical exam and medical history. They will also have an eye exam and blood tests. * This study will require at least ten visits to the National Institutes of Health eye clinic over a total of 52 weeks (one year). Most visits will last up to 4 hours. * Participants will return to the eye clinic 2 days after the first visit and 1, 2, 4, 8, 12, 24, 36 and 48 weeks after starting the study eye drops. These visits will involve blood tests and eye exams. * Participants will receive the study eye drops at the initial visit. The drops must be used three or four times a day for 2 weeks. They must be stored in a cool place (like a refrigerator). The doses will follow an escalation schedule with the first participant receiving 2 drops three times a day and the last participant receiving 4 drops four times a day. To maximize safety, the most-recently enrolled participant will complete Week 4 before the next participant can enroll (e.g., the second enrolled participant will not be enrolled until the first has completed the Week 4 visit). * If the CSC does not improve after the first 2 weeks, participants will receive another 2 weeks of eye drops. This set of drops will start 4 weeks after the initial study visit. * If the CSC does not improve after the 8-week study period, participants may receive ad
Interventions
- DRUG Interferon gamma-1b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01468337
The ClinicalTrials.gov registry entry for NCT01468337 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-1b is the first listed.
NCT01468337 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01468337 about?
NCT01468337 is a clinical study titled "Topical Interferon Gamma-1b for Central Serous Chorioretinopathy". Background: \- In the eye disease central serous chorioretinopathy (CSC), fluid collects under the retina at the back of the eye. CSC can resolve on its own, but in some people it lasts for several months or can come back. The fluid buildup during CSC can cause vision loss. The drug interferon gamm...
What is the current status of trial NCT01468337?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2011-10. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01468337?
The interventions under investigation include: Interferon gamma-1b (DRUG).
Who is sponsoring clinical trial NCT01468337?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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