Micropulse for Suppression of Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Percentage of Subjects With Vision Loss to 20/40 or Worse
研究概览
简要总结
Diabetic retinopathy is one of the most common complications of diabetes and diabetic macular edema (DME) is one of the most common causes of vision loss in diabetes.
The purpose of this study is to determine if early intervention with micropulse laser treatment in eyes with good visual acuity (20/32 or better) will improve or stabilize vision loss due to the complications of diabetic macular edema.
详细描述
This is a randomized, controlled clinical trial comparing subthreshold micropulse laser versus sham laser treatment for eyes with diabetic macular edema with good visual acuity of 20/32 or better.
Subjects will be randomized to receive either subthreshold micropulse laser treatment or no treatment (sham). Randomization will occur as a ratio of 2:1 and will take place during the clinic visit.
Subjects selected for the study will undergo a complete ophthalmic examination, including measurements of best corrected visual acuity, low luminance visual acuity, contrast sensitivity (using ETDRS testing with a masked coordinator), intraocular pressure, slit lamp exam including documentation of lens status, and dilated funduscopic exam with standard dilating agents used at the UC Davis Eye Center. Subjects will then undergo baseline imaging including Spectral Domain Ocular Coherence Tomography (SD-OCT), fundus autofluorescence (FAF) and microperimetry testing. Both the use of OCT, FAF, and microperimetry testing are within the standard of care for the management of DME.
The duration of an individual subject's participation in the study will be two years which will include at least 10 total visits at various time points including on the day of enrollment, followed by 1, 3, 6, 9, and 12, 15, 18, 21, 24 months after the day of enrollment.
The subjects in the treatment arm will be treated on the day of randomization by SML photocoagulation using the Iridex IQ577 laser unit with TxCell scanning laser delivery system.
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 (Participant, Outcomes Assessor)
盲法说明
Subjects will be masked to their treatment assignment. The research coordinator that performs the measurement of best corrected visual acuity will be masked to the treatment assignment. The reading center analyst responsible for reviewing and analyzing OCT and microperimetry reports will be masked to treatment assignment.
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
- •Age >=18 years
- •Type 1 or type 2 diabetes mellitus
- •Clinical evidence of center-involved DME confirmed on OCT, and defined by OCT
- •Central Subfield (CSF) thickness at the time of randomization by the following:
- •Zeiss Cirrus: 275μ in women, and 290μ in men
- •Heidelberg Spectralis: 290μ in women, and 305μ in men
- •Best corrected visual acuity of 20/32 or better on ETDRS testing
排除标准
- •Macular edema from causes other than DME
- •An ocular condition is present such that in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (i.e/foveal atrophy, pigment abnormalities, dense hard exudates)
- •An ocular condition is present other than DME which may contribute to macular edema (i.e/vein occlusion, ERM, uveitis, RP, etc...).
- •Cataract that in the opinion of the investigator may alter visual acuity throughout the course of the study
- •History of prior laser or other surgical, intravitreal, or peribulbar treatment for DME in the study eye within the prior 6 months.
- •More than 4 prior intraocular injections for treatment of DME at any time
- •More than 1 prior focal/grid macular photocoagulation session for treatment of DME at any time
- •History of topical steroid or NSAID treatment within 30 days prior to randomization
- •History of PRP within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
- •Any history of vitrectomy.
- •History of major ocular surgery (cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization
- •History of YAG capsulotomy performed within 2 months prior to randomization.
- •Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
结局指标
主要结局
Percentage of Subjects With Vision Loss to 20/40 or Worse
时间窗: 6 months
BCVA measured using ETDRS testing. The study endpoint was reached if the study patient experienced vision loss of ≥10 letters (≥2 lines) at any visit or 5-9 letters (1-2 lines) at 2 consecutive visits ≤28 days apart, based on the criteria for initiating anti-VEGF therapy as defined in the DRCR Protocol V study.
次要结局
- Visual Acuity at 6 Month(6 months)
- Low Luminance Visual Acuity at 6 Months(6 months)
- Contrast Sensitivity at 6 Months(6 months)
- Central Subfield Thickness (CST) at 6 Months(6 months)
- Microperimetry Average Threshold at 6 Month(6 months)