- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02125266
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
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Colorado
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Golden, Colorado, United States
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Georgia
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Atlanta, Georgia, United States
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Nebraska
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Omaha, Nebraska, United States
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Ohio
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Cleveland, Ohio, United States
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Texas
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Arlington, Texas, United States
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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)
|
Sustained Release
Other Names:
|
Experimental: High Dose V404 PDS
Sustained intravitreal delivery of methotrexate (2.3 mg)
|
Sustained Release
Other Names:
|
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
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
- Eye Diseases
- Panuveitis
- Uveal Diseases
- Choroid Diseases
- Choroiditis
- Uveitis
- Uveitis, Posterior
- Uveitis, Intermediate
- Pars Planitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
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.
Clinical Trials on Uveitis, Posterior
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Bausch & Lomb IncorporatedCompletedNoninfectious Posterior UveitisUnited States
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National Eye Institute (NEI)CompletedNon-infectious Intermediate and Posterior UveitisUnited States
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University of NebraskaUnknownPosterior Uveitis | Intermediate Uveitis | Pan-uveitisUnited States
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Duke UniversityCompletedPosterior Uveitis | Intermediate UveitisUnited States
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AllerganCompletedPosterior Uveitis | Intermediate UveitisFrance, United Kingdom, United States, Spain, Poland, India, South Africa, Korea, Republic of, Canada, Czech Republic, Australia, Germany, Israel, Switzerland, Portugal, Austria, Brazil, Greece
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Novartis PharmaceuticalsCompletedNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious PanuveitisUnited States, United Kingdom
-
EyePoint Pharmaceuticals, Inc.CompletedPanuveitis | Posterior Uveitis | Intermediate UveitisIndia
-
Johns Hopkins UniversityMacuSight, Inc.CompletedPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States