Uveitis, Intermediate Clinical Trial
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).
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05486468 -
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment
|
Phase 3 | |
| Terminated |
NCT03656692 -
Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
|
Phase 4 | |
| Completed |
NCT02255032 -
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
|
Phase 2 | |
| Recruiting |
NCT05101928 -
Ozurdex Monotherapy Trial
|
Phase 4 | |
| Terminated |
NCT05070728 -
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI)
|
Phase 3 | |
| Completed |
NCT02595398 -
Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
|
Phase 3 | |
| Completed |
NCT00344253 -
Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis
|
Phase 3 | |
| Active, not recruiting |
NCT05953688 -
POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU
|
Phase 2 | |
| Recruiting |
NCT06085079 -
Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study
|
Phase 4 | |
| Withdrawn |
NCT01905124 -
Safety &Efficacy of CF101 to Subjects With Uveitis
|
Phase 2 | |
| Completed |
NCT02049476 -
Study of the Effectiveness of Ozurdex for the Control of Uveitis
|
Phase 4 | |
| Completed |
NCT00404612 -
A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
|
Phase 3 | |
| Completed |
NCT00404742 -
A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
|
Phase 3 | |
| Completed |
NCT02952001 -
MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
|
||
| Completed |
NCT03097315 -
Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis
|
Phase 3 | |
| Terminated |
NCT02125266 -
Safety and Preliminary Efficacy Study of V404 PDS in Uveitis
|
Phase 1/Phase 2 |