A study to see how safe and how well an investigational study drug will work to treat active non-infectious posterior, intermediate or pan-uveitis.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. Ability to give informed consent and attend all study visits
2. Males or females greater than or equal to 18 years of age
3. Have diagnosis of active uveitis determined by the Investigator to be noninfectious based on the subject's medical history, history of present illness, ocular examination, review of systems, physical examination, and any relevant, pertinent laboratory evaluations. If an anterior component is present, it must be less than the posterior component
4. Have active uveitis defined as having >1+ (excluding 1+) vitreous haze score (SUN scale)
5. Best-corrected ETDRS visual acuity letter score of 19 letters or more (20/400 Snellen equivalent or better) in study eye
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 425
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

Ocular:
1. Active infectious uveitis. However, if the uveitis is the consequence of previous infectious disease, such as Tuberculosis, as long as the previous infectious disease is no longer active may be enrolled
2. Clinically suspected or confirmed central nervous system or ocular lymphoma
3. Primary diagnosis of anterior uveitis
4. Uncontrolled glaucoma, evidenced by an intraocular pressure of > 21 mmHg while on medical therapy, or chronic hypotony (<6 mmHg)
5. Any implantable corticosteroid-eluting device (e.g. Retisert, Ozurdex, I-vation, triamcinolone acetonide [TA] intravitreal implant):
a. If the investigator confirms the removal of such device more than 90 days prior to Day 1, the subject will be eligible;
b. If a subject received a Medidur implant, it should have been implanted no less than 3 years and 90 days prior to Day 1
6. Any significant ocular disease that could compromise vision in the study eye.
These include, but are not limited to:
a. Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or nonproliferative diabetic retinopathy (NPDR) that compromise vision.
Subjects with NPDR or PDR that does not compromise vision are not excluded from the study;
b. Wet age-related macular degeneration;
c. Myopic degeneration with active subfoveal choroidal neovascularization
7. Lens opacities or obscured ocular media other than vitreous haze upon enrollment such that reliable evaluations and grading of the posterior segment cannot be performed
8. Intraocular surgery within 90 days prior to Day 1 in the study eye
9. Capsulotomy within 30 days prior to Day 1 in the study eye
10. Any of the following treatments within 90 days prior to Day 1 or anticipated use of any of the following treatments to the study eye:
a. Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors);
b. Posterior subtenon steroids
11. Ocular or periocular infection in either eye
12. Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye
13. Media opacity that would limit clinical visualization, intravenous fluorescein angiography (IVFA), or OCT evaluation in the study eye
14. History of herpetic infection in the study eye or adnexa
15. Presence of known active, inactive toxoplasmosis or toxoplasmosis scar in either eye
16. Presence of any form of ocular malignancy in either eye including choroidal melanoma
Non-Ocular:
1. Allergy or hypersensitivity to study drug product or fluorescein dye
2. Participation in other investigational drug or device clinical trials within 30 days prior to Day 1, or planning to participate in other investigational drug or device clinical trials within 150 days following Day 1. This includes both ocular and non-ocular clinical trials.
3. Treatment with a monoclonal antibody or any other biologic therapy within the previous 30 days, or with alemtuzumab within the previous 12 months from Day 1
4. Immunosuppressive therapy (e.g., methotrexate, cyclosporine, cyclophosphamide, chlorambucil, mycophenolate mofetil, tacrolimus or azathioprine) other than prednisone or other corticosteroids for the treatment of uveitis within 30 days of the first study drug administration (Day 1)
5. Any recent systemic infection within 30 days of Screening
6. Known to be immunocompromised
7. History of cytomegalovirus infection or clinical evidence of active cytomegalovirus infection at Screening and/or Day 1
8. History of other disease, metabolic dysfunction, physic

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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