Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forsight Vision4
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 18 years of age or older

• Confirmed diagnosis of active uveitis

• Sufficient lens/media clarity

• Meet best-corrected visual acuity criteria

• Willing and able to use contraception

Exclusion Criteria:

• Pregnant, breast feeding

• 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