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Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02125266
Recruitment Status : Terminated (Study terminated due to unacceptable frequency of drug related adverse events)
First Posted : April 29, 2014
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
Forsight Vision4

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.

Condition or disease Intervention/treatment Phase
Uveitis, Posterior Uveitis, Intermediate Drug: V404 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose V404 PDS
Sustained intravitreal delivery of methotrexate (0.6 mg)
Drug: V404
Sustained Release
Other Name: Methotrexate

Experimental: High Dose V404 PDS
Sustained intravitreal delivery of methotrexate (2.3 mg)
Drug: V404
Sustained Release
Other Name: Methotrexate




Primary Outcome Measures :
  1. Frequency of adverse events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in vitreous haze score [ Time Frame: Baseline, 6 Months ]

Other Outcome Measures:
  1. Change in macular thickness by ocular coherence tomography [ Time Frame: Baseline, 6 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125266


Locations
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United States, Colorado
Golden, Colorado, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Texas
Arlington, Texas, United States
Sponsors and Collaborators
Forsight Vision4

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Responsible Party: Forsight Vision4
ClinicalTrials.gov Identifier: NCT02125266     History of Changes
Other Study ID Numbers: V4041
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Uveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Panuveitis
Choroiditis
Choroid Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors