Clinical trial NCT03727776: Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)
Official title: Adrenocorticotropic Hormone for Intraocular Inflammation in Post-operative Proliferative Vitreoretinopathy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Proliferative Vitreoretinopathy
Keywords: Post-operative Intraocular Inflammation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2018-11-01
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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.


Eligibility criteria: 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 poorly controlled diabetes mellitus (defined as HbA1C ≥ 8.0% on any anti-diabetic medications or insulin. If the patient is using any anti-diabetic medication/insulin, he becomes eligible if the medication is used continuously for \>30 days)
* Patients with poorly controlled hypertension (defined as systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>100 mm Hg at rest with up to 3 anti-hypertensive medications. If a patient's initial measurement exceeds these values, a second reading may be taken 30 or more mins later. If the patient is using any anti-hypertensives, he becomes eligible if the medication is used continuously for \>30 days)
* 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)

Primary outcomes:
measure: Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
timeFrame: Baseline, 1 day after surgery, 8 weeks after surgery
measure: Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
timeFrame: Baseline, 1 day after surgery, 8 weeks after surgery
measure: Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
timeFrame: Baseline, 1 day after surgery, 8 weeks after surgery
Secondary outcomes:
measure: Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
timeFrame: Baseline, 1 day after surgery, 1 week after surgery
measure: Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
timeFrame: Baseline, 1 day after surgery, 1 week after surgery
measure: Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
timeFrame: Baseline, 1 day after surgery, 1 week after surgery
measure: Change in mean grade of aqueous cell in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
timeFrame: 1 week, 4 weeks, 8 weeks and 12 weeks after surgery
measure: Change in mean grade of flare in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
timeFrame: 1 week, 4 weeks, 8 weeks and 12 weeks after surgery
measure: Change in best-corrected visual acuity as measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) score in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
timeFrame: Baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after surgery
measure: Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop recurrent retinal detachment
timeFrame: 12 weeks after surgery
measure: Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop macular edema
timeFrame: 12 weeks after surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute, Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Wilmer Eye Institute, Johns Hopkins School of Medicine
name: Peter A Campochiaro, MD
role: PRINCIPAL_INVESTIGATOR
References: