Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03727776
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2018-10-31
Brief Title:
Adrenocorticotropic Hormone ACTH for Post-op Inflammation in Proliferative Vitreoretinopathy PVR
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Adrenocorticotropic Hormone for Intraocular Inflammation in Post-operative Proliferative Vitreoretinopathy Patients
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study to measure levels of albumin and inflammatory cytokines including Transforming Growth Factor-Beta TGF-β and Interleukin-1 Beta IL-1β in the aqueous humor of post-operative proliferative vitreoretinopathy patients receiving subcutaneous injections of HP Acthar an adrenocorticotropic hormone ACTH analog The study will be conducted at the Wilmer Eye Institute Johns Hopkins Hospital A total of 15 patients will be enrolled and randomized 21 to HP Acthar or standard of care Treatment duration will be 8 weeks and study duration will be 12 weeks There will be a total of 7 study visits baseline day of surgery post-operative day 1 week 1 week 4 week 8 and week 12
Subjects will self-administer subcutaneous injections of 80 units of HP Acthar starting on post-operative day 1 for twice a week until week 8 Subjects in the control arm will be managed per the standard of care Aqueous samples will be obtained at the onset of surgery 1 day 1 week and 8 weeks after surgery Aqueous levels of albumin and inflammatory cytokines including TGF-β and IL-1β will be measured at each time point
Subjects will self-administer subcutaneous injections of 80 units of HP Acthar starting on post-operative day 1 for twice a week until week 8 Subjects in the control arm will be managed per the standard of care Aqueous samples will be obtained at the onset of surgery 1 day 1 week and 8 weeks after surgery Aqueous levels of albumin and inflammatory cytokines including TGF-β and IL-1β will be measured at each time point
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None