NCT06846073进行中（未招募）不适用
A Prospective Clinical Study on the Early Combined Use of Dexamethasone Intravitreal Implant and Anti-VEGF in the Treatment of Diabetic Macular Edema (DME) in Naive Patients.
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Average change in best corrected visual acuity (BCVA) of each group from baseline to the end of month 6.
研究概览
简要总结
The goal of this clinical trial is to learn if the efficacy of dexamethasone implant combined with anti-VEGF superior to anti-VEGF monotherapy in the treatment of DME in Chinese patients. The main questions it aims to answer are:
- Whether combination therapy improves the best corrected visual acuity at 6 months and 12 months?
- Does combination therapy improve retinal anatomy better than monotherapy at each time point?
Researchers will compare the combination therapy to the monotherapy to see if dexamethasone implant combined with anti-VEGF will leads to better results.
Participants will:
- be randomly assigned to one of two groups with equal probability to receive the combination of intravitreal anti-VEGF and dexamethasone implant injections or intravitreal anti-VEGF injections.
- During the first 3 months, patients in both groups will receive monthly injections of anti-VEGF. In the double protocol group, the first dexamethasone implant injection will be administered simultaneously with the first loading dose of anti-VEGF injections. Between 4 and 12 months, patients will receive intravitreal anti-VEGF injections as needed/pro-re-nata (PRN).
- Patients will have regular follow-up. Routine examination includes Central retinal thickness (CRT), intraocular pressure (IOP), slit lamp examination, best corrected visual acuity (BCVA) and OCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1/type 2 diabetes mellitus with good glycaemic control and glycated haemoglobin ≤ 10.0%; DR stage II-III;
- •DME with involvement of the central concavity and resulting in the patient's vision loss;
- •Central retinal thickness (CRT) ≥250 μm;
- •No refractive interval clouding and pupillary constriction affecting fundus examination;
- •No Pan-Retinal Photocoagulation treatment within 3 months before enrolment;
- •No macular laser treatment in the past or during the follow-up period;
- •Good patient cooperation and compliance.
排除标准
- •other macular lesions such as macular preexisting membranes, macular schisis, or other causes of macular oedema such as uveitis and central retinal vein occlusion;
- •Co-existence of diabetic optic neuropathy;
- •Previous intraocular injection therapy such as anti-VEGF drugs or glucocorticoid drugs in the target eye;
- •History of vitreoretinal surgery in the target eye;
- •A history of uncontrolled stable glaucoma or hypertension, hormonal hypertension in the target eye;
- •Aphakic eyes with posterior lens capsule rupture with an anterior chamber IOL (ACIOL), iris or transscleral fixed intraocular IOLs, and patients with posterior lens capsule rupture;
- •Pregnant or breastfeeding patients, uncontrolled hypertension within 3 months, cerebrovascular accident or myocardial infarction, uncontrolled diabetes mellitus, or other reasons for not being able to co-operate with the relevant examination;
- •Lost visits and data loss.
研究组 & 干预措施
The combination of intravitreal anti-VEGF and dexamethasone implants injections.
Experimental
The patients will receive the combination of intravitreal anti-VEGF and dexamethasone implants injections.
干预措施: The combination of intravitreal anti-VEGF and dexamethasone implants injections. (Combination Product)
Anti-VEGF injections monotherapy
No Intervention
The patients will receive intravitreal anti-VEGF injections.
结局指标
主要结局
Average change in best corrected visual acuity (BCVA) of each group from baseline to the end of month 6.
时间窗: 6 month.
BCVA was measured using the log Mar visual acuity chart or the ETDRS visual acuity chart.
次要结局
- Average change in best corrected visual acuity (BCVA) of each group from baseline to month 3, 12.(3 month and 12 month)
- Average change in central retinal thickness (CRT) of each group from baseline to month 3, 6,12.(3, 6 and 12 month)
- The proportion of eyes with a 5-letter /10-letter improvement from baseline of BCVA at month 6 and 12.(6 month and 12 month)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Pilot Study to Establish Safety & Efficacy of a Combination of Dexamethasone and Lenalidomide in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia (CLL)Chronic Lymphocytic LeukemiaNCT01459211University College, London12
已完成
4 期
Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular EdemaDiabetic Macular EdemaNCT04411693The Cleveland Clinic23
Unknown
4 期
Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular EdemaDiabetic RetinopathyNCT04448496Yeungnam University College of Medicine49
进行中（未招募）
不适用
Comparing Single Dose and Multiple Dose of Dexamethasone Post TKAPain, PostoperativeOsteo Arthritis KneeNCT06339151Thammasat University Hospital120
招募中
4 期
Evaluating the Effect of Intravenous Dexamethasone on the Duration of Spinal Anesthesia After Cesarean DeliverySpinal AnesthesiaDexamethasoneNCT05731960IWK Health Centre192