Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

Uveitis, Posterior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02125266
• Other study ID #: V4041
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 24, 2014
• Last updated: December 7, 2016
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: December 2016
• Source: Forsight Vision4
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uveitis
• Uveitis, Intermediate
• Uveitis, Posterior

Intervention

Drug:
• V404
Sustained Release

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Forsight Vision4

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in macular thickness by ocular coherence tomography		Baseline, 6 Months	No
Primary	Frequency of adverse events		6 months	Yes
Secondary	Change in vitreous haze score		Baseline, 6 Months	No