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Semax

ACTH(4-10) analogue, Heptapeptide SEMAX

Quick Stats
Studies 172
Trials 37
Completed EARLY PHASE1 INTERVENTIONAL NCT03727776

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: Adrenocorticotropic Hormone
Type: DRUG
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®).

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
Description: The levels of albumin in the aqueous humor are indicative of blood-retinal barrier breakdown and will be measured in mg/dl
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
Description: The levels of TGF-B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl
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
Description: The levels of IL-1B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl

Trial Information

NCT ID

NCT03727776

Status

Completed

Study Type

INTERVENTIONAL

Phases

EARLY PHASE1

Sponsor

Johns Hopkins University

Last Updated

December 15, 2025