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Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

Primary Purpose

Uveitis, Posterior, Uveitis, Intermediate

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
V404
Sponsored by
Forsight Vision4
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis, Posterior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Dose V404 PDS

High Dose V404 PDS

Arm Description

Sustained intravitreal delivery of methotrexate (0.6 mg)

Sustained intravitreal delivery of methotrexate (2.3 mg)

Outcomes

Primary Outcome Measures

Frequency of adverse events

Secondary Outcome Measures

Change in vitreous haze score

Full Information

First Posted
April 24, 2014
Last Updated
December 7, 2016
Sponsor
Forsight Vision4
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1. Study Identification

Unique Protocol Identification Number
NCT02125266
Brief Title
Safety and Preliminary Efficacy Study of V404 PDS in Uveitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to unacceptable frequency of drug related adverse events
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forsight Vision4

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Posterior, Uveitis, Intermediate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose V404 PDS
Arm Type
Experimental
Arm Description
Sustained intravitreal delivery of methotrexate (0.6 mg)
Arm Title
High Dose V404 PDS
Arm Type
Experimental
Arm Description
Sustained intravitreal delivery of methotrexate (2.3 mg)
Intervention Type
Drug
Intervention Name(s)
V404
Other Intervention Name(s)
Methotrexate
Intervention Description
Sustained Release
Primary Outcome Measure Information:
Title
Frequency of adverse events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in vitreous haze score
Time Frame
Baseline, 6 Months
Other Pre-specified Outcome Measures:
Title
Change in macular thickness by ocular coherence tomography
Time Frame
Baseline, 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Golden
State/Province
Colorado
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Arlington
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

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