NCT04005430进行中（未招募）1 期
A Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered From an Episcleral Reservoir for Treatment of Macular Edema Secondary to Diabetes and Other Causes
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The primary outcome measure of the study is safety assessment.
研究概览
简要总结
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.
详细描述
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision in patients with diabetic macular edema.
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
- •Type I or II diabetes;
- •Age >= 18 years;
- •Visual acuity letter score in study eye < 70 and ≥ 25 letters (approximate Snellen equivalent 20/32 to 20/320);
- •Ophthalmoscopic evidence of center-involved DME, within the central subfield (CSF);
- •OCT CSF thickness value (microns):
- •Zeiss Cirrus: ≥290 in women; ≥305 in men
- •Heidelberg Spectralis: ≥305 in women; ≥320 in men
- •Previous treatment with laser, anti-VEGF therapy and/or intravitreal steroids;
- •No previous history of glaucoma or steroid-induced intraocular pressure response in either eye.
排除标准
- •History of chronic renal failure requiring dialysis or kidney transplant;
- •Retinal or optic nerve neovascularization on clinical exam, fundus photographs, or fluorescein angiograms;
- •Evidence of external ocular infection;
- •History of open-angle glaucoma or intraocular pressure >= 25 mmHg;
- •History of steroid-induced IOP elevation that required IOP-lowering treatment;
- •History of prior herpetic ocular infection;
- •History of intravitreal or periocular corticosteroids within 3 months prior to enrollment;
- •History of macular laser photocoagulation within 4 months prior to enrollment;
- •History of antiangiogenic therapy within 4 weeks prior to enrollment;
- •History of panretinal photocoagulation (PRP) within 4 months prior to enrollment or anticipated need for PRP in the next 6 months following enrollment;
- •Presence of vitreomacular traction, epiretinal membrane, tractional retinal detachment, vitreous hemorrhage and or any ocular condition that the investigator judges could interfere in the safety and efficacy assessments;
- •No other major non-diabetic pathology, or anticipation of such in the next 6 months following enrollment that in the opinion of the investigator would substantially and adversely affect assessment of safety and toxicity during the study;
- •Participation in another clinical trial of non-approved medical treatment within 3 months prior to enrollment;
- •Degenerative myopia;
- •Malignant intraocular disease;
- •Inability to understand informed consent, cooperate with testing or return to follow up visits; Pregnant or lactating women; Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.
研究组 & 干预措施
Phase 1
Experimental
Phase I open label study
干预措施: Episcleral Dexamethasone (Drug)
结局指标
主要结局
The primary outcome measure of the study is safety assessment.
时间窗: 12 Months
The main outcome of the study is safety assessment.
次要结局
- Secondary outcome are assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).(12 Months)
- Secondary outcomes are assessment of visual acuity.(12 Months)
研究者
研究点 (1)
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