Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

Phase 2TerminatedNCT02125266

Forsight Vision47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Uveitis, Posterior Uveitis, Intermediate

Interventions

V404DRUG

Sustained Release

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Unnamed facility

Golden, Colorado, United States

Unnamed facility

Atlanta, Georgia, United States

Unnamed facility

Omaha, Nebraska, United States

Unnamed facility

Cleveland, Ohio, United States

Unnamed facility

Arlington, Texas, United States

Outcomes

Primary Outcomes

Frequency of adverse events

Time frame: 6 months

Secondary Outcomes

Change in vitreous haze score

Time frame: Baseline, 6 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.