Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
Conditions
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.
Interventions
DRUGActhar Gel
Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)
Sponsors
Mallinckrodt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Nussenblatt Grading Scale | Week 36 | The Nussenblatt grading scale uses photographic measurement of cloudy, declining vision (vitreous haze). The scale goes from 0 to 4, and lower scores are better. |
| Score on the Laser Flare Scale | Week 36 | Protein that escapes from blood vessels inside the eye make a sudden burst of scattered light (flare) when a laser shines on them. This is called a laser flare. It is used to measure the amount and size of proteins in the clear fluid in the front of the eyeball (aqueous humour). The larger the flare, the more inflammation is inside the eye (intraocular inflammation) in patients with uveitis. Laser flare is scored on a scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Lower scores are better. |
| Score on the Aqueous Cell Scale | Week 36 | The number of cells (like white blood cells) floating in the aqueous humour (aqueous cells) are measured on a scale from 0 (none) to 4 (more than 30 cells), and lower scores are better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diurnal Intraocular Pressure (IOP) | Week 36 | Eye pressure is measured in millimeters of mercury (mmHg). Normal eye pressure ranges from 12-22 mmHg, and eye pressure greater than 22 mmHg is considered higher than normal. During a 24-hour period, IOP normally varies by 2 to 6 mmHg because of different amounts of secretion and drainage at different times of the day. The word diurnal means around the day, and IOP means pressure inside the eye, so diurnal IOP is the measure of pressure inside the eye during a 24-hour period. Diurnal IOP is measured in millimeters of mercury (mmHg) using Goldmann Applanation Tonometry (GAT). Lower scores are better. |
Countries
United States
Participant flow
Recruitment details
Approximately 30 participants were planned, but only 5 enrolled before the study was terminated
Participants by arm
| Arm | Count |
|---|---|
| Acthar Gel Participants receive Acthar Gel | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Worsening of disease activity | 2 |
Baseline characteristics
| Characteristic | Acthar Gel |
|---|---|
| Age, Continuous | 58.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Score on the Aqueous Cell Scale
The number of cells (like white blood cells) floating in the aqueous humour (aqueous cells) are measured on a scale from 0 (none) to 4 (more than 30 cells), and lower scores are better.
Time frame: Week 36
Population: Data were not collected.
Primary
Score on the Laser Flare Scale
Protein that escapes from blood vessels inside the eye make a sudden burst of scattered light (flare) when a laser shines on them. This is called a laser flare. It is used to measure the amount and size of proteins in the clear fluid in the front of the eyeball (aqueous humour). The larger the flare, the more inflammation is inside the eye (intraocular inflammation) in patients with uveitis. Laser flare is scored on a scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Lower scores are better.
Time frame: Week 36
Population: Data were not collected.
Primary
Score on the Nussenblatt Grading Scale
The Nussenblatt grading scale uses photographic measurement of cloudy, declining vision (vitreous haze). The scale goes from 0 to 4, and lower scores are better.
Time frame: Week 36
Population: Data were not collected.
Secondary
Diurnal Intraocular Pressure (IOP)
Eye pressure is measured in millimeters of mercury (mmHg). Normal eye pressure ranges from 12-22 mmHg, and eye pressure greater than 22 mmHg is considered higher than normal. During a 24-hour period, IOP normally varies by 2 to 6 mmHg because of different amounts of secretion and drainage at different times of the day. The word diurnal means around the day, and IOP means pressure inside the eye, so diurnal IOP is the measure of pressure inside the eye during a 24-hour period. Diurnal IOP is measured in millimeters of mercury (mmHg) using Goldmann Applanation Tonometry (GAT). Lower scores are better.
Time frame: Week 36
Population: Data were not collected.