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NCT01314417 · ClinicalTrials.gov registry record · Phase 1
Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01314417 is a Phase 1 study that was terminated before completion, run by National Eye Institute (NEI). The registered enrollment target is 2 participants.
The verdict
NCT01314417, a Phase 1 study, was terminated before completion, sponsored by National Eye Institute (NEI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
BACKGROUND: Uveitis comprises of a group of diseases associated with inflammation of the eye that can lead to vision loss. Some people with uveitis also have macular edema (swelling of the retina at the back of the eye). Uveitis and macular edema are treated with medications and sometimes surgery, but treatment does not always prevent vision loss. Previous research has shown that injections of methotrexate into the eye of people with eye disease other than uveitis can help relieve the inflammation, or swelling, that causes macular edema and can slow visual loss. However, it has not yet been approved as a treatment for macular edema associated with uveitis. OBJECTIVES: To evaluate the safety and effectiveness of methotrexate injections as a treatment for macular edema associated with uveitis. ELIGIBILITY: Individuals at least 18 years of age who have been diagnosed with uveitis and macular edema in at least one eye. DESIGN: * This study requires at least nine visits to the National Eye Institute study clinic over a period of 6 months (24 weeks). * Participants will be screened with a physical and ophthalmic examination, medical history, blood and urine tests, and additional eye and other tests as needed. * Participants will receive a methotrexate injection in a selected treatment eye. After the injection, participants will receive antibiotic eye drops to place in the eye three times a day for the 3 days following the injection, leucovorin (folic acid) drops to place in the eye four times a day for 1 week following the injection, and a dose of folic acid to be taken by mouth the day after the injection. * Participants who tolerate the initial injection may continue to receive injections in their study eye every month for 6 months. After 6 months, participants who show improvement from the injections may be evaluated to receive additional injections every 4 to 8 weeks until researchers end the study.
Interventions
- DRUG Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01314417
The ClinicalTrials.gov registry entry for NCT01314417 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 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 Methotrexate is the first listed.
NCT01314417 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01314417 about?
NCT01314417 is a clinical study titled "Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate". BACKGROUND: Uveitis comprises of a group of diseases associated with inflammation of the eye that can lead to vision loss. Some people with uveitis also have macular edema (swelling of the retina at the back of the eye). Uveitis and macular edema are treated with medications and sometimes surgery, ...
What is the current status of trial NCT01314417?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2011-02. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01314417?
The interventions under investigation include: Methotrexate (DRUG).
Who is sponsoring clinical trial NCT01314417?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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