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.

Conditions: veitis of the Posterior Segment of the Eye.
MedDRA version: 17.0Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 100000004862
Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

Registration Number: EUCTR2011-001595-19-DE

Lead Sponsor: SANTEN INCORPORATED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

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 of the posterior segment 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 a >1+ (excluding 1+) VH score
(modified SUN scale) in the study eye
5. Best-corrected ETDRS visual acuity letter score of 19 letters or more (20/400 Snellen equivalent or better) in study eye
6. Female participants of childbearing potential must not be pregnant or breast-feeding, have a negative pregnancy test at Screening and must be willing to undergo pregnancy tests throughout the study
7. Both female participants of childbearing potential and male
participants able to father children must have (or have a partner who
has) had a hysterectomy or vasectomy, must abstain from intercourse or must agree to practice acceptable methods of contraception throughout the course of the study
8. Subjects must have vision = 20/200 in the non-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 520
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Ocular:
1. Active infectious uveitis. However, if the uveitis is the consequence of a previous infectious disease, such as Tuberculosis, the previous infectious disease must be confirmed as no longer active
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. Ozurdex, I-vation, Iluvien, triamcinolone acetonide [TA] intravitreal implant) in the study eye:
a. If the Investigator confirms the device has no demonstrable efficacy as indicated in the package insert, the subject will be eligible;
b. If a Medidur implant Iluvien or Retisert has, it should have been implanted no less than 3 years and 90 days prior to Day 1, the subject will be eligible
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
antivascular 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
17. History of vitrectomy in the study eye
Non-Ocular:
1. Allergy or hypersensitivity to study drug product or fluorescein dye or other study related procedures/medications
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 for the entire duration of the study. This includes both ocular and non-ocular clinical trials.
3. Treatment with a monoclonal antibody or any other biologic therapy (i.e. Etanercept, Tocilizumab, Adalimumab, Rituximab, etc.) 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, azathioprine or colchicine) 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and efficacy of intravitreal injection of 440 µg DE-109 as compared with 44 µg DE-109 for the treatment of active, noninfectious uveitis of the posterior segment of the eye.;Secondary Objective: To evaluate the safety of intravitreal injection of 880 µg DE-109 as<br>compared to 44 µg DE-109 for the treatment of active, non-infectious<br>uveitis of the posterior segment of the eye.;Primary end point(s): Vitreous haze (VH) 0 response: Having a VH score of 0 at Month 5 based<br>on the modified Standardized Uveitis Nomenclature (SUN) Photographic<br>scale.<br>;Timepoint(s) of evaluation of this end point: Month 5

Secondary Outcome Measures

Name	Time	Method

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