Uveitis of the Posterior Segment of the Eye. MedDRA version: 14.0 Level: LLT Classification code 10036370 Term: Posterior uveitis System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: DE-109
Product Code: DE-109
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sirolimus
CAS Number: 53123-88-9
Current Sponsor code: DE-109
Other descriptive name: RAPA
Co
Sponsors
SANTEN INCORPORATED
Eligibility
Sex/Gender
All
Inclusion criteria
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
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is the consequence of previous infectious disease, such as Tuberculosis, as long as the previous infectious disease is no longer active may be enrolled 2.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of DE-109 by comparing the proportion of subjects with vitreous haze score of 0 at Month 5 (SUN scale).;Secondary Objective: To evaluate the efficacy of DE-109 by comparing the: - Proportion of subjects with 2 or more unit change from baseline in vitreous haze score at Month 5 on SUN scale - Time to reach a vitreous haze score of 0 on SUN scale - Mean change from Baseline in vitreous haze score at Month 5 - Proportion of subjects on <5 mg/day of prednisone at Month 5 - Mean change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) at Month 5 - Mean change from Baseline in central foveal thickness as measured by optical coherence tomography (OCT) at Month 5 - Change from Baseline in the National Eye Institute (NEI) Visual Functioning Questionnaire-25 (VFQ-25);Primary end point(s): The primary endpoint is the proportion of responders with vitreous haze score of 0 at Month 5 (SUN scale).;Timepoint(s) of evaluation of this end point: Month 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy variables will include: - Proportion of subjects with 2 or more unit change from baseline in vitreous haze score at Month 5 - Time to achieve a vitreous haze score of 0 - Mean change from Baseline in vitreous haze score at Month 5 - Proportion of subjects on <5 mg/day of prednisone at Month 5 - Mean change from Baseline in ETDRS BCVA at Month 5 - Mean change from Baseline in central foveal thickness as measured by OCT at Month 5 - Change from Baseline in the NEI VFQ-25;Timepoint(s) of evaluation of this end point: Month 5 | — |
Countries
Argentina, Austria, Brazil, Chile, Colombia, Czech Republic, Dominican Republic, France, Germany, India, Israel, Italy, Mexico, Netherlands, Peru, Poland, Spain, Turkey, United Kingdom, United States, United States Minor Outlying Islands
Contacts
Public ContactAJ ACKER
SANTEN INCORPORATED
Outcome results
None listed