Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

December 7, 2016 updated by: Forsight Vision4

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Golden, Colorado, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Texas
      • Arlington, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose V404 PDS
Sustained intravitreal delivery of methotrexate (0.6 mg)
Drug: V404
Sustained Release
Other Names:
  • Methotrexate
Experimental: High Dose V404 PDS
Sustained intravitreal delivery of methotrexate (2.3 mg)
Drug: V404
Sustained Release
Other Names:
  • Methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of adverse events
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in vitreous haze score
Time Frame: Baseline, 6 Months
Baseline, 6 Months

Other Outcome Measures

Outcome Measure
Time Frame
Change in macular thickness by ocular coherence tomography
Time Frame: Baseline, 6 Months
Baseline, 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forsight Vision4

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V4041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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