Active, Non-Infectious Uveitis of the Posterior Segment of the Eye. MedDRA version: 20.0 Level: PT Classification code 10046851 Term: Uveitis System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Opsiria
Product Code: [DE-109]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sirolimus
CAS Number: 53123-88-9
Current Sponsor code: DE-109
Concentration unit: mg/ml mi
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 of at least 18 years of age. 3.Have diagnosis of active uveitis of the posterior segment determined by the investigator to be non-infectious 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 anterior segment inflammation is present, it must be less severe than the posterior component. 4.Have active uveitis at the Day 1 visit defined as a > or = 1.5+ VH score (modified SUN scale) in the study eye(s), as assessed by the investigator and confirmed by a central reading center. 5.Have a BCVA > or = 20 ETDRS letters (20/400 Snellen equivalent or better) and =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1.Confirmed/suspected infectious uveitis in either eye. If due to a previous infection this must be confirmed as no longer active or latent Ocular/periocular infection in either eye including (but not limited to): a.History of herpetic infection in the study eye(s) or adnexa b.Presence of known active/inactive toxoplasmosis or toxoplasmosis scar in either eye c.History of CMV/clinical evidence of active CMV infection at screening and/or D1 2.Primary diagnosis of anterior uveitis in the study eye(s) 3.The following conditions in the study eye(s) a.Ocular inflammation associated with Behcet’s Disease b.Serpiginous Choroiditis c.Punctate Inner Choroidopathy d.Acute Posterior Multifocal Placoid Pigment Epitheliopathy 4.Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye(s) 5.Media opacity (other than VH) limiting clinical visualization/OCT evaluation in the study eye(s) 6.Any existing lens opacity in the study eye(s) that in the opinion of the investigator could a.require surgical intervention during the 5-month study period or b.interfere with the grading of VH, or c.preclude evaluation of the posterior pole via fundus photography or OCT assessment 7.Corneal opacity in the study eye(s) that would preclude reliable assessment of the posterior segment 8.Uncontrolled glaucoma in the study eye(s) (IOP > 21 mmHg) while on medical therapy, or chronic hypotony (IOP 6 months prior to D1 allowed b.Fluocinolone acetonide implant implanted >3 yrs prior to D1 allowed 16.Immunosuppressive therapy <30 days of D1, other than prednisone or equivalent or permitted immunosuppressants 17.Treatment with a monoclonal antibody or any other biologic therapy <90 days prior to D1 18.Use of topical ocular application of marijuana/marijuana derivatives 19.Any intraocular surgery (excluding eyelid surgery and refractive laser surgery) in the study eye(s) <90 days prior to D1 20.Capsulotomy in the study eye(s) <30 days prior to D1 21.Clinically suspected or confirmed CNS/ocular lymphoma in either eye 22.Presence of any form of ocular malignancy in the either eye including choroidal melanoma 23.Malignancy in remission for <5 yrs prior to study participation (except basal cell or squamous cell skin cancer or treated melanoma of the skin <24 months since last treatment) 24.Allergy/hypersensitivity to investigational product/other study related procedures/medications 25.Any recent systemic infection (excl. common cold) <30 days of D1 26.Known to be immunocompromise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of intravitreal injection of 440 µg DE-109 every 2 months as compared with sham.;Secondary Objective: To evaluate the long-term efficacy (> 6 months and up to one year) of intravitreal injection of 440 µg DE-109 every 2 months. To evaluate the safety of intravitreal injection of 440 µg DE-109 every 2 months for up to one year of dosing.;Primary end point(s): To evaluate the efficacy of intravitreal injection of 440 µg DE-109 every 2 months as compared with sham. •VH 0 response at Month 3;Timepoint(s) of evaluation of this end point: Month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the long-term efficacy (> 6 months and up to one year) of intravitreal injection of 440 µg DE-109 every 2 months. To evaluate safety of intravitreal injection of 440 µg DE-109 every 2 months for up to 1 year of dosing;Timepoint(s) of evaluation of this end point: Long term efficacy > 6 months and up to one year. Safety every 2 month for up to 1 year of dosing. | — |
Countries
India, Italy, Spain, United States
Contacts
Public ContactVP, Vitreous & Retina TA Strategy
Santen Incorporated
Outcome results
None listed