Primary outcome· Week 36
Score on the Nussenblatt Grading Scale
| Group | Value |
|---|---|
| Acthar Gel | not posted |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataSafety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
NCTNCT03656692 (opens ClinicalTrials.gov in a new tab)Other idMNK61074105
This trial was stopped early.
Reason given at the registry: Logistical challenges; no safety concerns
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 4
- Enrollment
- 5 participants (actual)
- Sponsor
- Mallinckrodt · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 5 Oct 2018
- Primary completion
- 14 Jul 2020
- Completion
- 14 Jul 2020
- First posted
- 4 Sept 2018
- Last update posted
- 3 Aug 2021
- Conditions
- Uveitis, Posterior · Uveitis, Intermediate · Panuveitis
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2018201920202021
- Ph 4Terminated
Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
NCT036566925 Oct 2018 to 14 Jul 2020
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
- Acthar GelDrug
Arms1
Other
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.
Primary outcomes3
Outcomes the sponsor listed as primary.
Score on the Nussenblatt Grading Scale
Time frame · Week 36
Registry description
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
Time frame · Week 36
Registry description
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
Time frame · Week 36
Registry description
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 outcomes(1)
Diurnal Intraocular Pressure (IOP)
Time frame · Week 36
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcome· Week 36
Score on the Laser Flare Scale
| Group | Value |
|---|---|
| Acthar Gel | not posted |
Primary outcome· Week 36
Score on the Aqueous Cell Scale
| Group | Value |
|---|---|
| Acthar Gel | not posted |
Secondary and other outcome results(1)
Secondary outcome· Week 36
Diurnal Intraocular Pressure (IOP)
| Group | Value |
|---|---|
| Acthar Gel | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Acthar GelParticipants receive Acthar Gel | 0 / 5 | 0 / 5 | 5 / 5 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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