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
About this trial
This is an interventional treatment trial for Uveitis, Posterior
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
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
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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