JPRN-jRCTs031230213招募中Unknown
A Multicenter Clinical Trial to Investigate Optimization of an Individualized Dosing Regimen of Faricimab in Patients with Diabetic Macular Edema in the Clinical Setting - SWAN Study
Murata Toshinori0 个研究点目标入组 70 人开始时间: 2023年7月10日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •General selection criteria
- •1.Patients who have received informed consent.
- •2.18 years older at the time of informed consent.
- •3.Patients with a confirmed diagnosis of diabetes( type 1 or type 2).
- •4.Patients whose HbA1c was 10% or less within 2 months before Day1.
- •5.Patients who have will to participate and be able to attend all scheduled visits and examins.
- •Critesia for selection of target eye
- •Designate only one eye as the target eye.
- •1.If both eyes are eligible, select the eye with the worse BCVA at screening will be used unless the principal investigators determine that the other eye is more appropriate for treatment. Patients with macular thickening due to DME, including the fovea, and CST of 325 micrometre or more by Spectralis SD-OCT, or 315 micrometre or more by Cirrus SD-OCT or Topcon SD-OCT(or other equivalent OCT) at screening.
- •2. Patients with 0.0625 to 0.7 in visual acuity test (decimal visual acuity) performed at screening.
- •3.Patients with sufficiently clear intermediate translucency, dilated pupils, and capable of high quality CFP imaging and other imaging examinations.
排除标准
- •Exclusion criteria applied to the target eye
- •Patients who have
- •1.The high-risk PDR in the target eye
- •1) Vitreous hemorrhage or preretinal hemorrhage.
- •2) Neovascularization of 1/2 or more optic disc area than the optic disc area in ETDRS 7 directions under mydriasis detected by physical examination or CFP.
- •3) Neovascularization of more than one-third of the optic disc area detected on examination.
- •2.Tractional retinal detachment, preretinal fibrosis, vitreomacular traction syndrome, epiretinal membrane with foveal adhesion or macular structural disruption in the target eye.
- •3.An active rubeosis.
- •4. Poorly controlled glaucoma.
- •5.A history of retinal detachment or macular hole (stage 3 or 4)
- •6. An aphakic eye or intraocular lens inserted in the anterior chamber.
- •7.receiving intravitreal administration of anti-VEGF medication within 3 months before day1 (applicable to patients who have received intravitreal administration of anti-VEGF medication to the target eye). However, the inclusion rate of patients with a history of intravitreal administration of anti-VEGF medication should be less of 25% (=<17 cases).
- •8.Received PRP, macular laser treatment (focal, grid or micropulse), cataract surgery, steroid or YAG laser posterior capsulotomy within 3 months before day 1 for cataract surgery complications.
- •9.Undergone other intraocular surgery (e.g., corneal transplantation, glaucoma filtration surgery, pars plana vitrectomy, radiotherapy.
- •10.Received intravitreal or periocular (subtenon) steroid administration within 6 months before day1.
- •11. Received treatment for other retinal diseases that may leadto macular edema.
- •12.A history of intravitreal administration of faricimab.
研究者
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