Trial Outcomes & Findings for Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients (NCT NCT02764697)

Last Updated: 2018-07-02

Results Overview

Subjects will have fundus photography at baseline and 12 weeks. Intermediate uveitis is graded by haze; it is done using the photographic scale: grades 0-4 (lower values are a better outcome), utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

12 Weeks

Results posted on

2018-07-02

Participant Flow

The recruitment period was 06/31/2016 through 08/10/2016 Active follow-up period 06/31/2016 through 12/07/2016 The study was conducted at 1 site Tampa Bay Uveitis Center, LLC 5800 49th Street North, St Petersburg Fl 33709: Outpatient Medical Clinic

The patient after consent was given, were required to have their medical records reviewed and have screening laboratory evaluations

Participant milestones

Participant milestones
Measure	H.P. Acthar Subcutaneous Gel Injection For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete. H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly
Overall Study STARTED	5
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	H.P. Acthar Subcutaneous Gel Injection For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete. H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly
Overall Study Lack of Efficacy	3

Baseline Characteristics

Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	H.P. Acthar Subcutaneous Gel Injection n=5 Participants For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete. H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 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	4 Participants n=5 Participants
Race (NIH/OMB) White	1 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: 12 Weeks

Outcome measures

Outcome measures
Measure	H.P. Acthar Subcutaneous Gel Injection n=5 Participants For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete. H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly
Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography 2 Step of VH	1 Participants
Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography 1 Step of VH Improvement	3 Participants
Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography No VH Improvement	1 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 0

Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness \< 300 microns

Outcome measures

Outcome measures
Measure	H.P. Acthar Subcutaneous Gel Injection n=5 Participants For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete. H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly
Number of Participants With Clinically Significant Improvement of Macular Edema Decrease in Central Foveal Thickness <300	0 Participants
Number of Participants With Clinically Significant Improvement of Macular Edema Decrease in central Fovea > 300 Microns	5 Participants

Adverse Events

H.P. Acthar Subcutaneous Gel Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Grace Levy Clarke

Tampa Bay Uveitis Center, LLC

Phone: 855 798 8393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place