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

Proliferative Vitreoretinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727776
• Other study ID #: IRB00179012
• Status: Completed
• Phase: Early Phase 1
• Start date: August 19, 2019
• Est. completion date: July 7, 2023

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Inflammation
• Proliferative Vitreoretinopathy

Intervention

Drug:
• Adrenocorticotropic Hormone
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®).

Locations

Country	Name	City	State
United States	Wilmer Eye Institute, Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls	The levels of albumin in the aqueous humor are indicative of blood-retinal barrier breakdown and will be measured in mg/dl	Baseline, 1 day after surgery, 8 weeks after surgery
Primary	Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls	The levels of TGF-B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl	Baseline, 1 day after surgery, 8 weeks after surgery
Primary	Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls	The levels of IL-1B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl	Baseline, 1 day after surgery, 8 weeks after surgery
Secondary	Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls	The levels of albumin in the aqueous humor are indicative of blood-retinal barrier breakdown and will be measured in mg/dl	Baseline, 1 day after surgery, 1 week after surgery
Secondary	Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls	The levels of TGF-B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl	Baseline, 1 day after surgery, 1 week after surgery
Secondary	Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls	The levels of IL-1B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl	Baseline, 1 day after surgery, 1 week after surgery
Secondary	Change in mean grade of aqueous cell in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls	Aqueous cell is a clinical indicator of blood-retinal barrier breakdown and intraocular inflammation. It is assessed on slit-lamp examination and is graded on a scale from 0 to 4+, with 0 meaning no aqueous cell and 4+ meaning severe aqueous cell	1 week, 4 weeks, 8 weeks and 12 weeks after surgery
Secondary	Change in mean grade of flare in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls	Flare is a clinical indicator of blood-retinal barrier breakdown and intraocular inflammation. It is assessed on slit-lamp examination and is graded on a scale from 0 to 4+ with 0 meaning no flare and 4+ means severe flare	1 week, 4 weeks, 8 weeks and 12 weeks after surgery
Secondary	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	The ETDRS score is a standardized score to assess visual acuity used in clinical research. The score ranges from 0 to 100, with higher scores corresponding to better visual acuity (a score of 100 corresponding to a Snellen visual acuity of 20/10).	Baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after surgery
Secondary	Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop recurrent retinal detachment	Recurrent retinal detachment is a common complication of PVR. It will be diagnosed based on clinical exam and supporting information from diagnostic tests such as Optical Coherence Tomography.	12 weeks after surgery
Secondary	Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop macular edema	Macular edema is a common complication of intraocular surgery. It will be diagnosed based on clinical exam and supporting information from diagnostic tests such as Optical Coherence Tomography.	12 weeks after surgery