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

Completed · Phase 2

Conditions studied: Uveitis

In brief

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

Key facts

Study ID

NCT02931175

Run by

Quan Dong Nguyen

People needed

28

Starts

2017-11-10

Expected to finish

2021-10-28

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible for the study, patients will be required to meet the criteria of 1 of the 3 following disease cohorts:
• 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.

You may not qualify if…

• Subjects who have any of the following at the screening visit are not eligible for enrolment in this study:
• Any significant ocular disease that could compromise vision in the study eye. These include, but are not limited to:
• Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or non-proliferative diabetic retinopathy (NPDR) that compromise the vision.
• Age-related macular degeneration;
• Myopic degeneration with active subfoveal choroidal neovascularization.
• Advanced glaucoma status post trabeculectomy or tube/valve placement
• 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:
• Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors);
• Posterior subtenon's steroids.
• 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;
• Presence of any form of ocular malignancy in the study eye, including choroidal melanoma;
• History of herpetic infection in the study eye or adnexa;
• Presence of known active or inactive toxoplasmosis in either eye;
• Presence of ocular or periocular infection in either eye;
• Participation in other investigational drug or device clinical trials within 30 days prior to Day 0, or planning to participate in other investigational drug or device clinical trials within 180 days following Day 0. This includes both ocular and non-ocular clinical trials.
• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
• Prior treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are anti-cluster of differentiation (CD) 4, anti- cluster of differentiation (CD)5, anti-cluster of differentiation (CD) 3, anti-cluster of differentiation (CD)19 and anti-cluster of differentiation (CD)20.
• Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.
• Immunization with a live/attenuated vaccine within 4 weeks prior to baseline.
• Previous treatment with ACTHAR within 3 months of day 0 of study visit.

Where it is running

• Retina Vitreous Associates, Medical Group — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• Metropolitan Eye Research and surgery Institute — Waltham, Massachusetts, United States
• Retina Centers Professional Corporation - RCPC — Cleveland, Ohio, United States
• Retina Consultants of Houston — Bellaire, Texas, United States
• Texas Retina Assiciates — Dallas, Texas, United States
• TExas Retina Associates — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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