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Uveitis, IntermediatePhase 3MYCUV-IIT02NCT01092533

Myfortic for the Treatment of Non-infectious Intermediate Uveitis

A Phase 3 study testing Myfortic and Decortin in people with Uveitis, Intermediate, run by STZ eyetrial at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Uveitis, Intermediate
What is being tested?
Myfortic and Decortin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
5 sitesGermany
Study dates
Mar 2010to Oct 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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:
  • Postmenopausal females, defined as:
  • 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.
  • Females who had a hysterectomy and/or bilateral oophorectomy.

Who cannot join

  • 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
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  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Charité Universitätsmedizin Berlin, Augenklinik

    Berlin, 13353

  • Universitäts-Augenklinik Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Heidelberg, Interdisziplinäres Uveitiszentrum

    Heidelberg, 69120

  • Augenklinik der Ludwig-Maximilians-Universität München

    München, 80336

  • Augenabteilung am St. Franziskus-Hospital Münster

    Münster, 48145

Other trials in Germany

About this study

Official title: Myfortic (Enteric-coated Mycophenolate Sodium) for the Treatment of Non-infectious Intermediate Uveitis - a Prospective, Controlled, Randomized Multicenter Trial

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).

Read the 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.

Being tested
Myfortic, Decortin
Medical subject headings
Uveitis, Intermediate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyforticDrug

    Also called Mycophenolate Sodium

    Myfortic 360 mg BID (during week 1) Myfortic 720 mg BID (from week 2 on) Maintenance dose Decortin 5mg/d

  • DecortinDrug

    Also called Prednisolone

    Maintenance dose 5 mg/d

Study groups in NCT01092533
Study groupRoleWhat they receive
Mycophenolate sodium + PrednisoloneExperimentalMycophenolate sodium 1440 mg/day Prednisolone: initial dose 1 mg/kg/day, maintenance dose 5 mg/day
Receives: Drug: Myfortic; Drug: Decortin
PrednisoloneActive comparatorPrednisolone: initial dose 1 mg/kg/day, maintenance dose 5 mg/day
Receives: Drug: Decortin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from study entry to first relapse

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01092533
Sponsor's protocol ID
2009-009998-10
Other IDs
2009
Acronym
MYCUV-IIT02
Status last verified
May 2017
First submitted
23 Mar 2010
Last updated
9 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.

    PubMed 16196117

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

  • Chanaud NP 3rd, Vistica BP, Eugui E, Nussenblatt RB, Allison AC, Gery I. Inhibition of experimental autoimmune uveoretinitis by mycophenolate mofetil, an inhibitor of purine metabolism. Exp Eye Res. 1995 Oct;61(4):429-34. doi: 10.1016/s0014-4835(05)80138-1.

    PubMed 8549684

  • Zierhut M, Stubiger N, Aboalchamat W, Landenberger H, Bialasiewicz AA, Engelmann K. [Immunosuppressive therapy with mycophenolate mofetil (CellCept) in treatment of uveitis]. Ophthalmologe. 2001 Jul;98(7):647-51. doi: 10.1007/s003470170101. German.

    PubMed 11490743

  • Baltatzis S, Tufail F, Yu EN, Vredeveld CM, Foster CS. Mycophenolate mofetil as an immunomodulatory agent in the treatment of chronic ocular inflammatory disorders. Ophthalmology. 2003 May;110(5):1061-5. doi: 10.1016/S0161-6420(03)00092-7.

    PubMed 12750115

  • Lau CH, Comer M, Lightman S. Long-term efficacy of mycophenolate mofetil in the control of severe intraocular inflammation. Clin Exp Ophthalmol. 2003 Dec;31(6):487-91. doi: 10.1046/j.1442-9071.2003.00704.x.

    PubMed 14641155

  • Thorne JE, Jabs DA, Qazi FA, Nguyen QD, Kempen JH, Dunn JP. Mycophenolate mofetil therapy for inflammatory eye disease. Ophthalmology. 2005 Aug;112(8):1472-7. doi: 10.1016/j.ophtha.2005.02.020.

    PubMed 16061096

  • Siepmann K, Huber M, Stubiger N, Deuter C, Zierhut M. Mycophenolate mofetil is a highly effective and safe immunosuppressive agent for the treatment of uveitis : a retrospective analysis of 106 patients. Graefes Arch Clin Exp Ophthalmol. 2006 Jul;244(7):788-94. doi: 10.1007/s00417-005-0066-8. Epub 2005 Sep 15.

    PubMed 16163494

  • Mod A, Tamaska J, Adam E, Gidall J, Poros A, Kiraly A, Natonek K, Paloczi K, Hollan Z. [Importance of the detection of minimal residual disease in the management of acute leukemia]. Orv Hetil. 1991 Jun 16;132(24):1291-6, 1299. Hungarian.

    PubMed 1857605

  • Behrend M. Adverse gastrointestinal effects of mycophenolate mofetil: aetiology, incidence and management. Drug Saf. 2001;24(9):645-63. doi: 10.2165/00002018-200124090-00002.

    PubMed 11522119

  • Budde K, Curtis J, Knoll G, Chan L, Neumayer HH, Seifu Y, Hall M; ERL B302 Study Group. Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results of a 1-year study. Am J Transplant. 2004 Feb;4(2):237-43. doi: 10.1046/j.1600-6143.2003.00321.x.

    PubMed 14974945

  • Hachinski VC, Wilson JX, Smith KE, Cechetto DF. Effect of age on autonomic and cardiac responses in a rat stroke model. Arch Neurol. 1992 Jul;49(7):690-6. doi: 10.1001/archneur.1992.00530310032009.

    PubMed 1497494

  • Pleyer U, Ruokonen P, Schmidt N, Feist E, Hohne M, Stanojlovic S. [Mycophenol acid in ocular automimmune disorders--can we optimise this therapy?]. Klin Monbl Augenheilkd. 2008 Jan;225(1):66-9. doi: 10.1055/s-2008-1027134. German.

    PubMed 18236373

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Myfortic and Decortin in people with Uveitis, Intermediate, run by STZ eyetrial at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from study entry to first relapse (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01092533, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.

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