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Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
Plain-language guide to NCT03656692: phase 4 interventional trial of ACTH (Corticotropin), 5 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03656692
- Phase
- phase 4
- Status
- terminated early
- Start
- 2018-10-05
- Completion (planned or actual)
- 2020-07-14
- Participants
- 5 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Uveitis, Posterior; Uveitis, Intermediate; Panuveitis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested ACTH (Corticotropin).
Also, safety information when using it for this purpose will be collected.
It had 1 arm (groups): Acthar Gel (other).
The registry classes the interventions as drug.
Who Took Part
5 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: Is male or nonpregnant, nonlactating female. Has been diagnosed with current severe NIPPU. Has active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion. Has ≥ 2+ anterior chamber cells \[Standardization of Uveitis Nomenclature (SUN) criteria\]. Has ≥ 1.5+ vitreous haze.
The full record lists 8 inclusion and 2 exclusion criteria; among the exclusions: has type 1 or type 2 diabetes mellitus, tuberculosis, history of hepatitis, peptic ulcer, active infection, or any contraindication for treatment with acthar gel.
How the Study Was Run
The set-up was single-group and open-label.
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 2018-10-05 with completion listed for 2020-07-14.
It ran at 8 sites in United States (8).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Score on the Nussenblatt Grading Scale (time frame: Week 36). Score on the Laser Flare Scale (time frame: Week 36). Score on the Aqueous Cell Scale (time frame: Week 36).
It also tracked 1 secondary outcome, for example Diurnal Intraocular Pressure (IOP).
What This Means in Plain Language
Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 5 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the ACTH (Corticotropin) compound page, all human trials.
Our Notes on the Compound
ACTH (Corticotropin): The 39-amino-acid pituitary hormone that drives cortisol production; given as repository corticotropin (Acthar Gel).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.