Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-05

Study Completion Date

2020-07-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Uveitis, Posterior Uveitis, Intermediate Panuveitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acthar Gel

Participants received Acthar 1 mL (80 units \[U\]) subcutaneously (SC) 2 times per week for 36 weeks followed by a taper to Acthar 1 mL (80 U) SC once a week for 2 weeks, then 0.5 mL (40 U) SC once a week for 2 weeks.

Group Type OTHER

Acthar Gel

Intervention Type DRUG

Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)

Interventions

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Acthar Gel

Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)

Intervention Type DRUG

Other Intervention Names

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Corticotropin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No