Uveitis of the Posterior Segment of the Eye. MedDRA version: 14.1 Level: LLT Classification code 10036370 Term: Posterior uveitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: DE-109
Product Code: DE-109
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Rapamycin
CAS Number: 53123-8
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 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+) vitreous haze score (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 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of a previous infectious disease, such as Tuberculosis, the previous infectious disease must be confirmed as no longer active 2.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, 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 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 b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of intravitreal injection of three doses of DE-109 (44 µg, 440 µg, 880 µg) for the treatment of active, noninfectious uveitis of the posterior segment of the eye; Secondary Objective: To evaluate: • The long term safety of multiple intravitreal injections of 880 µg dose of DE-109 • The durability of effect of 880 µg dose(s) of DE-109. ; Primary end point(s): The primary endpoint : Proportion of subjects with a 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 endpoint(s): • Proportion of subjects with a vitreous haze score of 0 or a 2 unit improvement from baseline in vitreous haze score at Month 5 (SUN scale) • Proportion of subjects with a citreous haze score of 0 or 0.5+ at month 5 • Time to reach a vitreous haze score of 0 (SUN scale) • Mean change from Baseline in vitreous haze score at Month 5 (SUN scale) • Proportion of subjects on = 5 mg/day of prednisone (or equivalent dose of another corticosteroid) 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 retina 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) at Month 5 ;Timepoint(s) of evaluation of this end point: Month 5 | — |
Countries
Argentina, Austria, Brazil, Chile, Colombia, Dominican Republic, France, Germany, India, Israel, Italy, Mexico, Peru, Poland, Spain, Turkey, United Kingdom, United States, United States Minor Outlying Islands
Contacts
Public ContactAJ ACKER
SANTEN INCORPORATED
Outcome results
None listed