Trial record 1 of 35 for:    "Pars planitis"
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Myfortic for the Treatment of Non-infectious Intermediate Uveitis (MYCUV-IIT02)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by STZ eyetrial.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Novartis Pharmaceuticals
University Hospital Tuebingen
Information provided by:
STZ eyetrial
ClinicalTrials.gov Identifier:
NCT01092533
First received: March 23, 2010
Last updated: March 24, 2010
Last verified: March 2010
  Purpose

The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of enteric-coated mycophenolate sodium (Myfortic®) in combination with low-dose corticosteroids (Decortin H®) compared to a monotherapy with low-dose corticosteroids (Decortin H®) in subjects with chronic intraocular inflammation (non-infectious intermediate uveitis).


Condition Intervention Phase
Non-infectious Intermediate Uveitis
Drug: Myfortic
Drug: Decortin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Myfortic (Enteric-coated Mycophenolate Sodium) for the Treatment of Non-infectious Intermediate Uveitis - a Prospective, Controlled, Randomized Multicenter Trial

Resource links provided by NLM:


Further study details as provided by STZ eyetrial:

Primary Outcome Measures:
  • Time from study entry to first relapse [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A log-rank test will be used to evaluate differences between the treatment and control group with the null hypothesis of no differences in the survival distributions between the two groups and the alternative hypothesis of different survival distributions. A two-sided log-rank test will be used at a significance level of 0.05.


Estimated Enrollment: 144
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mycophenolate sodium + Decortin Drug: Myfortic
Myfortic 360 mg BID (during week 1) Myfortic 720 mg BID (from week 2 on) Maintenance dose Decortin 5mg/d
Drug: Decortin
Maintenance dose 5 mg/d
Active Comparator: Decortin Drug: Decortin
Maintenance dose 5 mg/d

Detailed Description:

Mycophenolate mofetil (MMF), a pro-drug containing mycophenolic acid (MPA) as active agent, is approved for the treatment of acute graft rejection after kidney-, heart- and liver-transplantation, and was shown in 1995 to be effective in inhibiting the development of experimental autoimmune uveoretinitis. Further studies proved it to be a safe and effective steroid-sparing immunomodulatory for reducing the recurrence rate of non-infectious intermediate uveitis in humans. Although the adverse effect profile of MMF is comparatively benign, gastrointestinal adverse effects are a major concern and may limit its clinical benefit, because they may necessitate dose reduction, interruption, or even discontinuation of MMF.

An enteric-coated formulation of mycophenolate sodium (EC-MPS, Myfortic) has been developed especially to reduce MPA-related gastrointestinal adverse events. This clinical trial is a prospective controlled study to evaluate whether a Myfortic based regimen will be able to reduce the probability of a relapse compared to steroid therapy alone and to test whether a Myfortic based therapy provides a superior behaviour compared to a steroid regimen.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a documented at least 6 months history of unilateral or bilateral intermediate uveitis either idiopathic or due to non-infectious systemic disease (e.g. sarcoidosis, multiple sclerosis)
  • Uveitis has to be considered to be active at the timepoint of enrolment according to at least one of the following criteria:

    • Grade 2+ or higher for vitreous haze
    • Grade 2+ or higher for anterior chamber cells
    • Presence of cystoid macular edema in OCT
    • Presence of retinal vessel leakage in FA
  • Considered by the investigator to require systemic treatment.
  • At least 18 years of age
  • Not planning to undergo elective ocular surgery during the study
  • Capable of understanding the purposes and risks of the study, able to give informed consent and to comply with the study requirements
  • Subjects of both gender with reproductive potential who are sexually active agree to use contraception throughout the course of the study and for at least 3 months after completion of their study participation.
  • Women of childbearing potential have to use a highly effective method of birth control defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, hormonal IUDs combined with barrier methods (e.g. condom, diaphragm or spermicide), sexual abstinence or vasectomised partner.
  • Women of childbearing age must have a negative urine pregnancy test (UPT) within 48 hours prior to starting study drug and must not be lactating.

Female subjects of non-childbearing potential must meet at least one of the following criteria:

  1. Postmenopausal females, defined as:

    c. Females over the age of 60 years. d. Females who are 45 to 60 years of age must be amenorrheic for at least 2 years.

  2. Females who had a hysterectomy and/or bilateral oophorectomy.

Exclusion Criteria:

  • Uveitis of infectious etiology
  • Signs of tuberculosis in chest x-ray during the past 12 months before study entry
  • Clinically suspected or confirmed central nervous system or ocular lymphoma
  • Primary diagnosis of anterior or posterior uveitis
  • Uncontrolled glaucoma or known steroid response
  • Subjects who received treatment with a systemic immunosuppressive drug, a monoclonal antibody or any other biologic therapy within 90 days prior study entry
  • Treatment with mycophenolate mofetil or mycophenolate sodium in the past
  • Treatment with a periocular steroid injection within 6 weeks prior to study entry
  • Presence of absolute contraindications for Decortin H and/or Myfortic as mentioned in the product informations (Appendix 1 and 2)
  • Presence of relative contraindications for Decortin H and/or Myfortic as mentioned in the product information (Appendix 1 and 2) if the disorder leading to the relative contraindication can not sufficiently managed by concomitant medication.
  • Recipients of a solid organ transplant
  • Subjects with lens opacities or obscured ocular media upon enrolment making unable evaluation of the posterior eye segment
  • Subjects with a history of herpes zoster or varicella infection within 3 months before enrollment
  • Active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents or the history/presence of active hepatitis A, B or C
  • Seropositivity for human immunodeficiency virus (HIV)
  • Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) ≥ 2x upper limit of normal (ULN)
  • Severe anemia (hemoglobin < 8 g/dL), leukopenia (white blood cell count [WBC] < 2500 mm3), thrombocytopenia (platelet count < 80,000 mm3)
  • Current malignancy or a history of malignancy within the previous 5 years
  • Pregnant or lactating women
  • Known allergy for fluorescein natrium
  • Currently participating in another clinical trial with an investigational agent in the 30 days prior to study participation and/or has not recovered from any reversible effects or side effects of prior investigational agent
  • Subjects with non-ocular, medically significant co-morbid conditions that impair normal activities, require systemic corticosteroids or immunosuppressives, or any medical condition that would likely have an impact on the participant´s ability to comply with the study visit schedule
  • Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092533

Contacts
Contact: Christoph Deuter, Dr. +49 7071 2983721 christoph.deuter@med.uni-tuebingen.de

Locations
Germany
Charité Universitätsmedizin Berlin, Augenklinik Not yet recruiting
Berlin, Germany, 13353
Principal Investigator: Uwe Pleyer, Prof.         
Universitäts-Augenklinik Freiburg Not yet recruiting
Freiburg, Germany, 79106
Principal Investigator: Thomas Neß, Dr.         
Universitätsklinikum Heidelberg, Interdisziplinäres Uveitiszentrum Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Friederike Mackensen, Dr.         
Augenklinik der Ludwig-Maximilians-Universität München Not yet recruiting
München, Germany, 80336
Principal Investigator: Stephan Thurau, Prof.         
Augenabteilung am St. Franziskus-Hospital Münster Not yet recruiting
Münster, Germany, 48145
Principal Investigator: Arnd Heiligenhaus, Prof.         
Sponsors and Collaborators
STZ eyetrial
Novartis Pharmaceuticals
University Hospital Tuebingen
Investigators
Principal Investigator: Christoph Deuter, Dr. Centre for Ophthalmology, University of Tuebingen
  More Information

Publications:
Whitcup SM. Intermediate uveitis. In: Nussenblatt RB, Whitcup SM (eds.). Uveitis. Fundamentals and clinical practice. Elsevier publishers 2004: 291-300

Responsible Party: Christoph Deuter Dr., Centre for Ophthalmology, University of Tübingen, Germany
ClinicalTrials.gov Identifier: NCT01092533     History of Changes
Other Study ID Numbers: 2009-009998-10
Study First Received: March 23, 2010
Last Updated: March 24, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Pars Planitis
Chorioretinitis
Uveitis
Uveitis, Intermediate
Choroid Diseases
Choroiditis
Eye Diseases
Panuveitis
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior
Mycophenolate mofetil
Mycophenolic Acid
Prednisone
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014