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Myfortic for the Treatment of Non-infectious Intermediate Uveitis (MYCUV-IIT02)

S

STZ eyetrial

Status and phase

Completed
Phase 3

Conditions

Uveitis, Intermediate

Treatments

Drug: Decortin
Drug: Myfortic

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01092533
2009-009998-10

Details and patient eligibility

About

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).

Full 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.

Enrollment

44 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Mycophenolate sodium + Prednisolone
Experimental group
Description:
Mycophenolate sodium 1440 mg/day Prednisolone: initial dose 1 mg/kg/day, maintenance dose 5 mg/day
Treatment:
Drug: Myfortic
Drug: Decortin
Prednisolone
Active Comparator group
Description:
Prednisolone: initial dose 1 mg/kg/day, maintenance dose 5 mg/day
Treatment:
Drug: Decortin

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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