JPRN-jRCTs031180182已完成4 期
Exploratory clinical study to examine the efficacy of the simultaneous subthreshold retinal-photocoagulation and the intravitreal injection of VEGF inhibitors for diabetic macular edema - Simultaneous subthreshold retinal-photocoagulation and intravitreal injection of VEGF inhibitors for DME
Tatsumi Tomoaki0 个研究点目标入组 51 人开始时间: 2019年3月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
研究概览
简要总结
A prospective randomized controlled trial was conducted to examine the efficacy and safety of treatment for diabetic macular edema in two groups, an anti-VEGF treatment monotherapy group and combination therapy group of a anti-VEGF treatment and subthreshold laser. There was no significant difference in the number of anti-VEGF injections, CRT, and BCVA(logMAR) between the monotherapy group and the combination therapy group, and no additional effect was observed on the improvement of diabetic macular edema.
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
- •1. Japanese male and female >= 18 years with type 1 or 2 diabetes mellitus
- •2. DME with central involvement in the study eye
- •3. Decrease in vision determined to be primarily the result of DME in the study eye
- •4. central macular thickness >= 300 micrometer in the study eye
- •5. BCVA of 0.7 to 0.05 in the study eye
- •6. Subject must be competent to understand the information ICF and must sign the form
- •7. An eye with thicker patina when both eyes meet the above criteria
排除标准
- •1.Laser photocoagulation (panretinal or macular) in the study eye within 90 days prior to the first dose
- •2.Previous use of intraocular or periocular corticosteroids in the study eye within 120 days prior to the first dose
- •3.Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days prior to the first dose
- •4.Active proliferative diabetic retinopathy (PDR) in the study eye
- •5.Uncontrolled diabetes mellitus
- •6.Medical history of vitreoretinal surgery and scleral buckling
- •7.Medical history of filtering operation for glaucoma treatment and subject is expected to treat that operation in future
- •8.Medical history of idiopathic or autoimmune uveitis
- •9.Central vision is significantly affected by existing Vitreous tug syndrome or preretinal membrane
- •10.Existing iris neovascularization, vitreous hemorrhage and/or traction retinal detachment
- •11.Preretinal fibrosis extending to macular
- •12.Structural damage of central macular preventing improvement of visual acuity after regression of macular edema, such as atrophy of retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia, or structural hard spot
- •13.Posibility of low vision to conduct medical or surgical interventions during the study period, complications which should affect the study result
- •14.Cataract surgery or other intraocular surgery within 90 days prior to the first dose
- •15.Capsulotomy after yttrium aluminum garnet (YAG)lesser treatment within 30 days prior to the first dose
- •16.Three or more times of Macular lesser treatment (excluding direct coagulation for microaneurysm), or judged no responder to lesser treatment
- •17.Subject has developed symptoms of infectious blepharitis, corneitis, leucitis or conjunctivitis
- •18.Insufficient degree of clearness of optic media for the fundus imaging and OCT imaging
- •19.Subject has treated for serious systemic infectious disease
- •20.Poor controlled hypertension (sitting systolic pressure > 160mmHg and/or diastolic pressure > 95mmHg
- •21.Renal failure indicating dialysis or renal transplantation
- •22.An event of cerebrovascular disease or myocardial infarction within 180 days prior to the first dose
- •23.Systemic treatment of angiogenic inhibitor within 180 days prior to the first dose
- •24. High risk subject, who will affect study results or develop complications, based on medical records, metabolic dysfunction, or laboratory test findings indicating a disease and/or conditions for that the test drug will be contraindicated
- •25.Allergy to fluorescein
- •26.Female subject who is pregnant or breastfeeding, or who hopes to become pregnancy during the study period
- •27.Subjects judged not to be adequate by the investigator
研究者
相似试验
尚未招募
不适用
Moderate Depressive Disorder With Cheek AcupunctureAcupunctureDepressionNCT05923021The First Affiliated Hospital of Zhejiang Chinese Medical University126
Unknown
2 期
Dapsone for Acute Ischemia Stroke StudyCerebral StrokeCerebrovascular Accident, AcuteCerebrovascular StrokeStroke, AcuteStrokeNCT01144650Cidat, S.A. de C.V.300
尚未招募
1 期
To study efficacy of Bramhi Ghrita in Mild Cognitive Impairment (Smrutimandya/ memory loss )CTRI/2023/08/056170PDESs College of Ayurveda and Research Centre Nigdi Pune
Unknown
4 期
A Prospective Study of Cyclophosphamide Treatment for Idiopathic Retroperitoneal FibrosisIdiopathic Retroperitoneal FibrosisNCT04762810Peking Union Medical College Hospital40
撤回
不适用
Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise CapacityMyocardial DiseasesCoronary Artery DiseaseCongestive Heart FailureIschemic CardiomyopathyNCT00326690BioVentrix