Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
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 H.P. 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 2:1 to H.P. 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 H.P. 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.