Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis

What Was Tested

This registered phase 4 trial tested ACTH (Corticotropin).

It had 1 arm (groups): H.P. ACTHAR GEL (experimental).

The registry classes the interventions as drug.

Who Took Part

40 planned participants were the target.

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: If both eyes are involved, both are eligible for inclusion in the study. Willing and able to sign the informed consent form.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: patients under age 18; patients who are pregnant (must be ruled out in women of child-bearing age); patients with history of malignancy, except for dermatologic entities of basal or squamous cell carcinoma which have been completely excised or removed previously.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label ACTH (Corticotropin) study: the participants and staff both knew the treatment.

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

It started in 2017-03-22 with completion listed for 2020-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of responders to Acthar at the end of treatment (time frame: 24 Weeks).

It also tracked 3 secondary outcomes, for example Presence or absence of active retinal vasculitis at all other time points and Percentage of patients requiring rescue therapy.

What This Means in Plain Language

Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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