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

What Was Tested

In this early phase 1 trial, researchers set out to test ACTH (Corticotropin).

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.

It had two arms (groups): H.P. Acthar ® (experimental) and Controls (no intervention).

Subjects will be managed per the standard of care.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: patients with congestive heart failure; patients with scleroderma; patients with osteoporosis.

How the Study Was Run

The set-up was randomized, single-group and open-label.

The participants were allocated by chance, so the ACTH (Corticotropin) group and the comparison group should start out alike.

Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-08-19 with completion listed for 2023-07-07.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls (time frame: 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 (time frame: 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 (time frame: Baseline, 1 day after surgery, 8 weeks after surgery).

It also tracked 8 secondary outcomes, for example Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls, Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls, Change in mean grade of aqueous cell in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls, Change in mean grade of flare in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls and Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop macular edema.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of ACTH (Corticotropin) in 11 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, all human trials.