Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)

Adrenocorticotropic Hormone for Intraocular Inflammation in Post-operative Proliferative Vitreoretinopathy Patients

Sponsors

Lead Sponsor: Johns Hopkins University

Collaborator: Mallinckrodt

Source Johns Hopkins University
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.

Overall Status Recruiting
Start Date August 19, 2019
Completion Date December 2021
Primary Completion Date August 2021
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls Baseline, 1 day after surgery, 8 weeks after surgery
Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls Baseline, 1 day after surgery, 8 weeks after surgery
Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls Baseline, 1 day after surgery, 8 weeks after surgery
Secondary Outcome
Measure Time Frame
Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls Baseline, 1 day after surgery, 1 week after surgery
Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls Baseline, 1 day after surgery, 1 week after surgery
Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls Baseline, 1 day after surgery, 1 week after surgery
Change in mean grade of aqueous cell in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls 1 week, 4 weeks, 8 weeks and 12 weeks after surgery
Change in mean grade of flare in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls 1 week, 4 weeks, 8 weeks and 12 weeks after surgery
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 Baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after surgery
Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop recurrent retinal detachment 12 weeks after surgery
Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop macular edema 12 weeks after surgery
Enrollment 15
Condition
Intervention

Intervention Type: Drug

Intervention Name: Adrenocorticotropic Hormone

Description: Adrenocorticotropic hormone (ACTH) is a melanocortin peptide hormone that is normally produced in the pituitary gland and acts as a major regulator of adrenal cortex function. It stimulates the adrenal cortex to produce and secrete glucocorticoids. ACTH is available for clinical usage as an injectable gel (H.P. Acthar®).

Arm Group Label: H.P. Acthar ®

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Peter A Campochiaro, MD Principal Investigator Wilmer Eye Institute, Johns Hopkins School of Medicine
Overall Contact

Last Name: Gulnar Hafiz, MD, MPH

Phone: 4105020768

Email: [email protected]

Location
Facility: Status: Contact: Wilmer Eye Institute, Johns Hopkins Hospital Gulnar Hafiz, MD, MPH
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: H.P. Acthar ®

Type: Experimental

Description: Subjects will self-administer subcutaneous injections of 80 units of adrenocorticotropic hormone analog starting on post-operative day 1 for twice a week until week 8.

Label: Controls

Type: No Intervention

Description: Subjects will be managed per the standard of care.

Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov