EUCTR2019-003638-18-IT进行中（未招募）1 期
MINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 µg DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye. - LUMINA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 145
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 < or = 75 ETDRS letters (20/32 Snellen equivalent or worse) in the study eye(s) at the Day 1 visit.
- •6.Subjects being treated with one of the following: methotrexate, azathioprine and mycophenolate mofetil (or an equivalent drug, e.g., mycophenolic acid) may be enrolled if the dose has remained stable for at least 30 days prior to Day 1 and is anticipated to remain stable until the end of the trial. Subject that satisfy this Inclusion criteria may not be treated with any other systemic immunosuppressant therapy and consequently cannot also satisfy the criteria described in Inclusion criteria #7.
- •7.Subjects being treated with systemic (oral) corticosteroids must have received a stable oral prednisone-equivalent dose between =15 mg/day and =40 mg/day that has remained stable for at least 1 week (7 days) prior to and including on Day 1. These subjects will comprise the Intent-to-Taper population and will be required to taper from oral corticosteroids starting on Day 1. Subject that satisfy this Inclusion criteria may not be treated with any other systemic immunosuppressant therapy and consequently cannot also satisfy the criteria described in Inclusion criteria #6.
- •8.Subjects being treated with topical corticosteroid eye drops (excluding difluprednate ophthalmic emulsion) or topical non-steroidal anti-inflammatory eye drops must have received stable dosing (same medication type and frequency of use) for at least 7 days prior to Day 1 in the study eye(s). Decreases and termination of dose are allowable during the study.
- •9.Female subjects of childbearing potential must not be pregnant or breast-feeding, must have a negative serum pregnancy test at screening, and must be willing to undergo pregnancy tests throughout the study.
- •10.Female subjects of childbearing potential and male subjects able to father children must (a) have (or have a partner who has) had a hysterectomy or vasectomy, (b) abstain from intercourse throughout the course of the study, or (c) agree to practice acceptable methods of contraception throughout the course of the study (i.e., intrauterine device, oral contraceptives, barrier method, or other contraception deemed adequate by the investigator).
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •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 mmHg)
- •9.Any active ocular disease other than uveitis that could compromise vision in the study eye(s). Including but not limited to
- •a.Diabetic retinopathy
- •c.Myopic degeneration with active subfoveal choroidal neovascularization
- •10.History of vitrectomy in the study eye(s)
- •11.Presence of epiretinal membrane that according to investigator’s judgement will limit improvement of macular edema
- •12.Any ocular condition in the study eye(s) that would prevent improvement in visual acuity
- •13.Use of difluprednate ophthalmic emulsion eye drops in the study eye(s) <7 days prior to D1. These are prohibited throughout the the study
- •14.Any of the following treatments prior to D1 or anticipated use of any of the following treatments to the study eye(s)
- •a.Intravitreal injections of anti-VEGF <30 days of D1
- •b.Intravitreal or posterior subtenon steroids <90 days of D1
- •15.Any implantable CS-eluting device in the study eye(s) with the following exceptions
- •a.Ozurdex implanted >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
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