Study Stopped
Study terminated due to unacceptable frequency of drug related adverse events
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
1 other identifier
interventional
7
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2014
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedDecember 9, 2016
December 1, 2016
6 months
April 24, 2014
December 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of adverse events
6 months
Secondary Outcomes (1)
Change in vitreous haze score
Baseline, 6 Months
Other Outcomes (1)
Change in macular thickness by ocular coherence tomography
Baseline, 6 Months
Study Arms (2)
Low Dose V404 PDS
EXPERIMENTALSustained intravitreal delivery of methotrexate (0.6 mg)
High Dose V404 PDS
EXPERIMENTALSustained intravitreal delivery of methotrexate (2.3 mg)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Forsight Vision4lead
Study Sites (5)
Unknown Facility
Golden, Colorado, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Arlington, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2014
First Posted
April 29, 2014
Study Start
April 1, 2014
Primary Completion
October 1, 2014
Study Completion
March 1, 2015
Last Updated
December 9, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share