Safety and Preliminary Efficacy Study of V404 PDS in Uveitis
- Registration Number
- NCT02125266
- Lead Sponsor
- Forsight Vision4
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Dose V404 PDS V404 Sustained intravitreal delivery of methotrexate (0.6 mg) High Dose V404 PDS V404 Sustained intravitreal delivery of methotrexate (2.3 mg)
- Primary Outcome Measures
Name Time Method Frequency of adverse events 6 months
- Secondary Outcome Measures
Name Time Method Change in vitreous haze score Baseline, 6 Months