Trial Outcomes & Findings for Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer) (NCT NCT03656692)
NCT ID: NCT03656692
Last Updated: 2021-08-03
Results Overview
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.
TERMINATED
PHASE4
5 participants
Week 36
2021-08-03
Participant Flow
Approximately 30 participants were planned, but only 5 enrolled before the study was terminated
Participant milestones
| Measure |
Acthar Gel
Participants receive Acthar Gel
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Acthar Gel
Participants receive Acthar Gel
|
|---|---|
|
Overall Study
Worsening of disease activity
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
Baseline characteristics by cohort
| Measure |
Acthar Gel
n=5 Participants
Participants receive Acthar Gel
|
|---|---|
|
Age, Continuous
|
58.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 36Population: Data were not collected.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 36Population: Data were not collected.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 36Population: Data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 36Population: Data were not collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
Acthar Gel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acthar Gel
n=5 participants at risk
Participants receive Acthar Gel
|
|---|---|
|
Eye disorders
Iris adhesions
|
20.0%
1/5 • Up to 44 weeks
Treatment Emergent non-serious adverse events and all serious adverse events are reported. Treatment emergent adverse events are those that started or got worse after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Up to 44 weeks
Treatment Emergent non-serious adverse events and all serious adverse events are reported. Treatment emergent adverse events are those that started or got worse after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
|
|
Immune system disorders
Drug hypersensitivity
|
20.0%
1/5 • Up to 44 weeks
Treatment Emergent non-serious adverse events and all serious adverse events are reported. Treatment emergent adverse events are those that started or got worse after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
|
|
Investigations
Intraocular pressure increased
|
40.0%
2/5 • Up to 44 weeks
Treatment Emergent non-serious adverse events and all serious adverse events are reported. Treatment emergent adverse events are those that started or got worse after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
|
|
Psychiatric disorders
Insomnia
|
40.0%
2/5 • Up to 44 weeks
Treatment Emergent non-serious adverse events and all serious adverse events are reported. Treatment emergent adverse events are those that started or got worse after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
|
|
Eye disorders
Uveitis
|
60.0%
3/5 • Up to 44 weeks
Treatment Emergent non-serious adverse events and all serious adverse events are reported. Treatment emergent adverse events are those that started or got worse after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place