Safety and Preliminary Efficacy Study of V404 PDS in Uveitis
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Ocular |
| Therapuetic Areas: | Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2015 |
| Start Date: | April 2014 |
| Contact: | Signe Erickson, PhD |
| Email: | serickson@fsv4.com |
| Phone: | 650-223-8103 |
A Prospective, Multi-Center, Randomized, Controlled Clinical Trial Designed to Evaluate the Safety and Preliminary Efficacy of V404 PDS in Chronic Noninfectious Uveitis
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.
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.
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
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