CompletedPhase 2

ACTH as A Re-emerging theRapy for Uveitis (The ACTHAR Study)

United States28 participantsStarted 2017-11-10

Plain-language summary

The study aims to evaluate the potential role of ACTH gel in the management of non-infectious uveitis.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Active disease and are receiving no treatment. Active disease is defined as having at least 1+ Vitreous Haze using the Standardized Uveitis Nomenclature (SUN) Working Group scale and/or at least 1+ Vitreous Cell Count using Foster \& Vitale scale.
✓. Active disease and are receiving prednisone ≥10 mg/day (or equivalent dose of another corticosteroid) or at least 1 other systemic immunosuppressant (all systemic immunosuppressants other than corticosteroids will be discontinued 30 days prior to the first administration of the study drug on Day 0). Patients receiving combination of prednisone ≥10 mg/day and at least one other systemic immunosuppressant are also eligible in this category.
✓. Have inactive disease, defined as having \<= 0.5+ Vitreous Haze OR \<= 0.5+ Vitreous Cell Count (SUN scale), and are receiving prednisone ≥10 mg/day (or equivalent dose of another corticosteroid) or at least 1 other systemic immunosuppressant (all systemic immunosuppressants other than corticosteroids will be discontinued 30 days prior to the first administration of the study drug on Day 0). Patients receiving combination of prednisone ≥10 mg/day and at least one other systemic immunosuppressant are also eligible in this category.

✕. Any significant ocular disease that could compromise vision in the study eye. These include, but are not limited to:
✕. Any of the following treatments within 90 days prior to Day 0 or anticipated use of any of the following treatments to the study eye:
✕. Intraocular surgery within 90 days prior to Day 0 in the study eye;
✕. Capsulotomy within 30 days prior to Day 0 in the study eye;
✕. Any known ocular surgery (including cataract extraction or capsulotomy) of the study eye anticipated within the first 180 days following Day 0;
✕. Intraocular pressure(IOP) ≥25 mmHg in the study eye (glaucoma patients maintained on no more than 2 topical medications with IOP \<25 mmHg are allowed to participate);
✕. Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye;
✕. Media opacity that would limit clinical visualization;

Incidence of ocular adverse events (AEs)

Timeframe: Month 6

Incidence of systemic adverse events (AEs)

Timeframe: Month 6

NCT IDNCT02931175

SponsorQuan Dong Nguyen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-03

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Active disease and are receiving no treatment. Active disease is defined as having at least 1+ Vitreous Haze using the Standardized Uveitis Nomenclature (SUN) Working Group scale and/or at least 1+ Vitreous Cell Count using Foster \& Vitale scale.
✓. Active disease and are receiving prednisone ≥10 mg/day (or equivalent dose of another corticosteroid) or at least 1 other systemic immunosuppressant (all systemic immunosuppressants other than corticosteroids will be discontinued 30 days prior to the first administration of the study drug on Day 0). Patients receiving combination of prednisone ≥10 mg/day and at least one other systemic immunosuppressant are also eligible in this category.
✓. Have inactive disease, defined as having \<= 0.5+ Vitreous Haze OR \<= 0.5+ Vitreous Cell Count (SUN scale), and are receiving prednisone ≥10 mg/day (or equivalent dose of another corticosteroid) or at least 1 other systemic immunosuppressant (all systemic immunosuppressants other than corticosteroids will be discontinued 30 days prior to the first administration of the study drug on Day 0). Patients receiving combination of prednisone ≥10 mg/day and at least one other systemic immunosuppressant are also eligible in this category.

✕. Any significant ocular disease that could compromise vision in the study eye. These include, but are not limited to:
✕. Any of the following treatments within 90 days prior to Day 0 or anticipated use of any of the following treatments to the study eye:
✕. Intraocular surgery within 90 days prior to Day 0 in the study eye;
✕. Capsulotomy within 30 days prior to Day 0 in the study eye;
✕. Any known ocular surgery (including cataract extraction or capsulotomy) of the study eye anticipated within the first 180 days following Day 0;
✕. Intraocular pressure(IOP) ≥25 mmHg in the study eye (glaucoma patients maintained on no more than 2 topical medications with IOP \<25 mmHg are allowed to participate);
✕. Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye;
✕. Media opacity that would limit clinical visualization;