EUCTR2017-003243-37-GB进行中（未招募）1 期
Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial - MERIT Trial
MUST Coordinating Centre, John Hopkins Bloomberg School of Public Health0 个研究点目标入组 240 人开始时间: 2017年9月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- •1.18 years of age or older;
- •Eye level inclusion criteria - at least one eye must meet all of the following conditions
- •2.Inactive or minimally active non-infectious anterior, intermediate, posterior or panuveitis, as defined by SUN132 criteria as = 0.5+ anterior chamber cells, = 0.5+ vitreous haze grade and no active retinal/choroidal lesions for a minimum of 4 weeks;
- •3.Macular edema (ME) defined as the presence of macular thickness greater than the normal range for the OCT machine being used (see cut points below), regardless of the presence of cysts, following an intravitreal corticosteroid injection (= 4 weeks following intravitreal triamcinolone injection or = 12 weeks following intravitreal dexamethasone implant injection);
- •Greater than 300 µm for Zeiss Cirrus
- •Greater than 320 µm for Heidelberg Spectralis
- •Greater than 300 µm for Topcon 3DOCT
- •4.Baseline fluorescein angiogram that, as assessed by the study ophthalmologist, is gradable for degree of leakage in the central subfield;
- •5.Best corrected visual acuity (BCVA) 5/200 or better;
- •6.Baseline intraocular pressure > 5 mm Hg and = 21 mm Hg (current use of =3 intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable (Note: combination medications, e.g., Combigan, are counted as two IOP-lowering medications);
- •7.Media clarity and pupillary dilation sufficient to allow OCT testing and assessment of the fundus.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.History of infectious uveitis in either eye;
- •2.History of infectious scleritis of any type in either eye (Note: History of noninfectious scleritis that has been active in past 12 months is an eye-level exclusion –see #13 below);
- •3.History of keratitis (with the exception of keratitis due to dry eye) in either eye;
- •4.History of central serous retinopathy in either eye;
- •5.Active infectious conjunctivitis in either eye;
- •6.Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose = 10 mg per day at baseline that has not been stable for at least 4 weeks (note: if patient is off of oral prednisone at baseline (M01 study visit) dose stability requirement for past 4 weeks does not apply);
- •7.Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks (note: use of systemic methotrexate is acceptable as long as regimen has been stable for at least 4 weeks);
- •8.Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
- •9.Known allergy or hypersensitivity to any component of the study drugs;
- •10.For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;
- •Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions
- •11.History of infectious endophthalmitis;
- •12.History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of = 0.9 or any notching of optic nerve to the rim);
- •13.History of active noninfectious scleritis in past 12 months (Note: History of noninfectious scleritis is acceptable if the last episode of active scleritis resolved at least 12 months prior to enrollment);
- •14.Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (i.e., causing substantial wrinkling of the retinal surface);
- •15.Torn or ruptured posterior lens capsule
- •16.Presence of silicone oil;
- •17. Ozurdex administered in past 12 weeks;
- •18.Anti-VEGF agent, intravitreal methotrexate, or intravitreal/periocular corticosteroid administered in past 4 weeks;
- •19.Fluocinolone acetonide implant (Retisert) placed in past 3 years.
研究者
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