Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | April 10, 2019 |
| End Date: | July 10, 2021 |
| Contact: | Gulnar Hafiz, MD, MPH |
| Email: | ghafiz1@jhmi.edu |
| Phone: | 4105020768 |
Adrenocorticotropic Hormone for Intraocular Inflammation in Post-operative Proliferative Vitreoretinopathy Patients
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 10 patients will be enrolled.
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. 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.
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 10 patients will be enrolled.
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. 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.
Inclusion Criteria:
- Age ≥ 18 years
- Signed informed consent and authorization of use and disclosure of protected health
information
- Patients undergoing surgery for retinal detachment due to PVR
Exclusion Criteria:
- Patients with a known diagnosis of diabetes mellitus (or those with HbA1C ≥ 6.5%)
- Patients with hypertension (clinically diagnosed and on antihypertensive medication)
- Patients with congestive heart failure
- Patients with scleroderma
- Patients with osteoporosis
- Patients with active systemic fungal infection
- Patients with active ocular herpes simplex
- Patients with prior or active bleeding peptic ulcer
- Pregnant patients or patients who wish to become pregnant during the course of the
study (females of child-bearing age will be counselled to use contraception for the
duration of the study)
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