- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03473964
(ACTH) for the Treatment of Sarcoid Uveitis (ACTH)
Adrenocorticotrophic Hormone (ACTH) for the Treatment of Sarcoid Uveitis
Study Overview
Detailed Description
The Investigator seeks to determine the efficacy of H.P. Acthar® Gel (40 units twice weekly injection) of on disease activity and severity in patients with sarcoid uveitis. The retrospective study will evaluate a series of quantitative outcome measures:
The degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 3 weeks, 6 weeks, 12 weeks and 24 weeks.
The degree of aqueous flare as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 4 weeks,12 weeks and 24 weeks.
Best Corrected Visual Acuity at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks.
Central Macular Thickness at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by Optical Coherence Tomography (OCT).
Intraocular pressure at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by applanation tonometry
Quality of life assessment using National Eye Institute Visual Function Questionnaire (VFQ-25)
The Investigator expects to retrospectively review the charts of 10 sarcoid associated uveitis patients treated with Acthar® Gel over a period of 1 year.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: John J Huang, MD
- Phone Number: 203-288-2020
- Email: jjqhuang@yahoo.com
Study Contact Backup
- Name: Leslie D Hurst, MS
- Phone Number: 203-288-2020
- Email: lhurst@retinamd.com
Study Locations
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Connecticut
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Hamden, Connecticut, United States, 06518
- New England Retina Associates
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Presence of Sarcoid Uveitis as determined by
- clinical exam
- fluorescence angiography
- optical coherence tomography
Exclusion Criteria:
- Presence of long acting intraocular depots
- Women of childbearing age not using contraceptives
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Treatment
The study intervention is the observation of study subjects who have received H.P. Acthar® Gel (adrenocorticotrophic hormone), 40 units twice weekly injections in patients who have sarcoid uveitis and to assess it's effectiveness by measuring changes the degree of aqueous and vitreous inflammatory cells present, the degree of aqueous flare, and changes in visual acuity, macular thickness, intraocular pressure and quality of life measures assessed by using the National Eye Institute Visual Function Questionnaires (VFQ-25)
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H.P. Acthar gel: Injection 40 mg twice weekly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of aqueous and vitreous inflammatory cells-change is being assessed
Time Frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks.
|
Degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN)
|
0 weeks, 4 weeks, 12 weeks and 24 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of aqueous flare- change is being assessed
Time Frame: 0 weeks, 4 weeks 12 weeks and 24 weeks
|
Degree of aqueous flare as graded by the criteria established by Standardization of Uveitis Nomenclature (SUN)
|
0 weeks, 4 weeks 12 weeks and 24 weeks
|
Visual acuity- change is being assessed
Time Frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
|
Testing and evaluation of best corrected visual acuity using Luxvision trial frames and Precision Vision ETDRS charts R,1 and 2
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0 weeks, 4 weeks, 12 weeks and 24 weeks
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Central macular thickness- change is being assessed
Time Frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
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Central macular thickness as measured by Spectralis Optical Coherence Tomography (OCT)
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0 weeks, 4 weeks, 12 weeks and 24 weeks
|
Intraocular pressure
Time Frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
|
Intraocular pressure as measured by applanation tonometry
|
0 weeks, 4 weeks, 12 weeks and 24 weeks
|
Quality of life assessment- change is being assessed
Time Frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
|
Quality of life assessment using the National Eye Institute Visual Function Questionnaire (VFQ-25).
The VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single item general health rating question.
The scoring ranges in scores from 1-6, 1 being activity presents no difficulty and 6 being can no longer perform this activity due to vision.
The VFQ-25 generates the following vision-targeted subscales : global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision(2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (I), and ocular pain (2).
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0 weeks, 4 weeks, 12 weeks and 24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John J Huang, MD, New England Retina Associates
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1169914
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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