Myfortic for the Treatment of Non-infectious Intermediate Uveitis

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: STZ eyetrial
• Collaborators: Novartis Pharmaceuticals; University Hospital Tuebingen
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisone

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