Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

A Prospective, Multi-Center, Randomized, Controlled Clinical Trial Designed to Evaluate the Safety and Preliminary Efficacy of V404 PDS in Chronic Noninfectious Uveitis

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02125266

Enrollment

Registered

2014-04-29

Start date

2014-04-30

Completion date

2015-03-31

Last updated

2016-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveitis, Intermediate, Uveitis, Posterior

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.

Interventions

DRUGV404

Sustained Release

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency of adverse events	6 months

Secondary

Measure	Time frame
Change in vitreous haze score	Baseline, 6 Months

Other

Measure	Time frame
Change in macular thickness by ocular coherence tomography	Baseline, 6 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026