CTRI/2014/02/004379招募中4 期
A 12 month, open label, multi-center study to evaluate the efficacy and safety of intravitreal injections of ranibizumab 0.5 mg on Cystoid, Spongy & Mixed OCT patterns secondary to Diabetic Macular Edema (DME) - LUCID
Dr V Narendran0 个研究点目标入组 300 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Patients must be >=18 years of age who have signed an informed consent.
- •2.Having Type 1 or Type 2 diabetes mellitus.
- •3.Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator.
- •4.BCVA score between 78 and 39 letters, inclusively, using ETDRS-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160).
- •5.Retinal thickness >250 µm by OCT.
- •6.OCT scan acquisition possible.
排除标准
- •A) Presence of Ocular concomitant conditions/ diseases
- •1.Active intraocular inflammation (grade trace or above) in either eye.
- •2.Any active infection (e.g. keratitis, scleritis, uveitis, endophthalmitis) in either eye
- •3.History of uveitis in either eye.
- •4.Structural damage within 0.5 disc diameter of the center of the macula in the study eye, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques.
- •5.Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia).
- •6.Uncontrolled glaucoma in either eye.
- •7.Neovascularization of the iris in either eye.
- •8.Evidence of vitreomacular traction in either eye.
- •9.Active proliferative diabetic retinopathy in the study eye (active PDR means below)
- •-patients who need a PRP(panretinal photocoagulation) treatment immediately
- •-patients with pre-retinal hemorrhage
- •-patients with vitreous hemorrhage
- •B)Received Ocular treatments as noted below:
- •1.Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study
- •2.Focal/grid laser photocoagulation in the study eye within 3 months prior to study entry
- •3.Treatment with anti-angiogenic drugs in study eye within 3 months
- •4.Any intraocular surgery in the study eye within 3 months or planned during trial duration
- •5.History of vitrectomy in study eye
- •6.History of intravitreal corticosteroid treatment in phakic study eye
- •7.Intravitreal corticosteroids in post-cataract surgery study eye (aphakic or pseudophakic, without damaged posterior capsule) within 3 months
- •C)Systemic conditions or treatments
- •1.History of stroke
- •2.Untreated diabetes mellitus: HbA1C level12
- •3.Untreated or uncontrolled hypertension: SBP 160mmHg or DBP100mmHg
- •4.Pregnant or nursing (lactating) women
- •5.Inability to comply with study or follow-up procedures
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