Safety and Preliminary Efficacy Study of V404 PDS in Uveitis
NCT ID: NCT02125266
Last Updated: 2016-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
7 participants
INTERVENTIONAL
2014-04-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low Dose V404 PDS
Sustained intravitreal delivery of methotrexate (0.6 mg)
V404
Sustained Release
High Dose V404 PDS
Sustained intravitreal delivery of methotrexate (2.3 mg)
V404
Sustained Release
Interventions
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V404
Sustained Release
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of active uveitis
* Sufficient lens/media clarity
* Meet best-corrected visual acuity criteria
* Willing and able to use contraception
Exclusion Criteria
* Uncontrolled glaucoma
* Intraocular surgery or periocular/intraocular injections within 6 weeks
* Periocular or intraocular steroid within 3 months
* Prior vitrectomy
* Prior corneal transplant
* Prior fluocinolone implant
* Allergy or sensitivity to study drug
* Participation in other trial within 30 days
* Abnormal liver function
* History of positive serum tuberculosis test
18 Years
ALL
No
Sponsors
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Forsight Vision4
INDUSTRY
Responsible Party
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Locations
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Golden, Colorado, United States
Atlanta, Georgia, United States
Omaha, Nebraska, United States
Cleveland, Ohio, United States
Arlington, Texas, United States
Countries
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Other Identifiers
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V4041
Identifier Type: -
Identifier Source: org_study_id