Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema: The Multicenter DANTE Study
试验速览
- 阶段
- 4 期
- 入组人数
- 49
- 试验地点
- 7
- 主要终点
- Mean change of best corrected visual acuity
研究概览
简要总结
The purpose of the investigator's study is to evaluate the efficacy and safety profile of the pro re nata (PRN) regimen to 12 months by using intravitreal dexamethasone implant in eyes with treatment-naive diabetic macular edema patients.
详细描述
Pathogenesis of diabetic macular edema (DME) involves inflammation, angiogenesis, and oxidative stress processes provoked mainly by cytokines such as interleukin (IL)-6, 8, and monocyte chemotactic protein, and vascular endothelial growth factor (VEGF). Vision loss associated with diabetic retinopathy is most commonly caused by DME, which affects approximately 7% of all diabetic patients. Several therapeutic options are available for treating DME. Evidence for the use of these therapies is accumulating; however, the optical treatment choice remains unclear. In recent years, using intravitreal anti-VEGF agents to treat DME has been shown to be beneficial. Anti-VEGF injections are generally considered suitable first-line therapy for center-involved DME and are effective in improving visual acuity (VA), with 10% to 40% of patients achieving significant improvement in best-corrected visual acuity (BCVA) after 1 year of treatment.
The management of DME is complex, and often multiple treatment approaches are needed. Although anti-VEGF agents were effective for the treatment of DME, there is a proportion of patients who do not achieve optimal response to these agents, presenting refractory or persistent DME. Intravitreal administration of steroids for the treatment of DME has also been studied for many years due to their well-known, widespread, anti-inflammatory effects. Dexamethasone implant is a slow-release dexamethasone delivery system developed for intravitreal administration that has recently been introduced as a therapeutic option in DME.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male and females 18 years of age or older
- •Written informed consent has been obtained
- •Diabetic macular edema with a central macular thickness (CMT) ≥ 300um measured by spectral domain optical coherence tomography.
- •Treatment-naïve subjects for diabetic macular edema.
- •Documented BCVA of ETDRS letter score of 23 to 73 letters (Snellen equivalent of 20/320 to 20/40) in the study eye.
排除标准
- •Previous panretinal photocoagulation (PRP) or macular laser photocoagulation in the study eye
- •Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for diabetic macular edema
- •Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study
- •Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1
- •Elevated intraocular pressure or a history of steroid-induced ocular hypertension
- •The presence of other retinopathies, maculopathies, visually significant cataract, vitreomacular traction, peripheral ischemia, history of pars plana vitrectomy
- •Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening
- •Any history of allergy to povidone iodine
研究组 & 干预措施
Arms
Diabetic macular edema Dexamethasone 0.7mg is injected into the vitreous cavity. Center-involved macular edema secondary to diabetic retinopathy for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit)
干预措施: Dexamethasone implant (Drug)
结局指标
主要结局
Mean change of best corrected visual acuity
时间窗: From baseline to month 6
The mean change of best corrected visual acuity from baseline to Month 6 in early treatment diabetic retinopathy (ETDRS) letter score by using Logarithm of the Minimum Angle of Resolution (LogMAR) chart
次要结局
- Proportion (%) of subjects who gain ≥ 15 letters in best corrected visual acuity(Compared with baseline at month 6 and 12)
- Mean change in central macular thickness(From baseline to month 6 and 12)
- Mean treatment interval between injections(From baseline to month 12)
- Mean change of best corrected visual acuity(From baseline to month 12)
- Changes of total area (mm^2)of nonperfusion within the ETDRS grid using fluorescein angiography and optical coherence tomography angiography(From baseline to month 12)
- Mean number of injections(From baseline to month 12)
研究者
Min Sagong
Professor
Yeungnam University College of Medicine