Clinical trial NCT03656692: Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
Official title: A Multicenter, Open Label Pilot Study to Explore the Efficacy and Safety of Acthar Gel in Subjects With Severe Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis (NIPPU)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Uveitis, Posterior
Uveitis, Intermediate
Panuveitis
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2018-09-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main reason for this study is to see if Acthar Gel can reduce inflammation in the uvea.

Also, safety information when using it for this purpose will be collected.


Eligibility criteria: Inclusion criteria:

* Is male or nonpregnant, nonlactating female
* Has been diagnosed with current severe NIPPU
* Has active disease at the Baseline Visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone (or oral corticosteroid equivalent):

  1. Has active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
  2. Has ≥ 2+ anterior chamber cells \[Standardization of Uveitis Nomenclature (SUN) criteria\]
  3. Has ≥ 1.5+ vitreous haze
* Is willing to taper current doses of corticosteroid and immunomodulatory therapy to the minimum effective dose during the study.
* If under treatment with any immunosuppressants, immunomodulators, or biologic agents for a comorbid condition, has been on a stable dose for 2 weeks before screening

Exclusion criteria:

* Has proliferative or severe nonproliferative diabetic retinopathy, clinically significant macular edema due to diabetic retinopathy, neovascular/wet age-related macular degeneration, abnormality of vitreoretinal interface with the potential for macular structural damage independent of the inflammatory process or severe vitreous haze that precludes visualization of the fundus at the Baseline Visit
* Has Type 1 or Type 2 diabetes mellitus, tuberculosis, history of hepatitis, peptic ulcer, active infection, or any contraindication for treatment with Acthar Gel

Primary outcomes:
measure: Score on the Nussenblatt Grading Scale
timeFrame: Week 36
measure: Score on the Laser Flare Scale
timeFrame: Week 36
measure: Score on the Aqueous Cell Scale
timeFrame: Week 36
Secondary outcomes:
measure: Diurnal Intraocular Pressure (IOP)
timeFrame: Week 36
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Blue Ocean Clinical Research
state: Florida
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Waltham
country: United States
facility: Massachusetts Eye Research and Surgery Institution (MERSI)
state: Massachusetts
city: Palisades Park
country: United States
facility: Metropolitan Eye Research and Surgery Institute
state: New Jersey
city: Fargo
country: United States
facility: Bergstrom Eye Research, LLC
state: North Dakota
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: San Antonio
country: United States
facility: Foresight Studies, LLC
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Mallinckrodt
name: Clinical Team Lead
role: STUDY_DIRECTOR
References: