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Evaluation of the Effects of Selective Photocoagulation for the Treatment of Diabetic Macular Edema (SRT)

2016年9月6日 更新者:Lumenis Be Ltd.

Phase III Multi Center Study Study of the Effects of Selective Retinal Photocoagulation for the Treatment of Diabetic Macular Edema

The population of people suffering from diabetes is rapidly increasing, from an estimated 110 million in 1994 to 221 million in 2010. Diabetic macular edema is the most common reason for reduction in visual acuity in diabetic patients.

The standard care for diabetic macular edema is focal and /or grid retinal photocoagulation. During photocoagulation, small laser burns are applied to the retina, the sensory tissue that lines the back of the eye. Studies have shown that photocoagulation of clinically significant diabetic macular edema substantially reduces the risk of visual loss, increase the chance of visual improvement and decrease the frequency of persistent macular edema. However, it remains unknown whether the destruction of sensory layer of the retina during photocoagulation that may cause visual field defects is necessary for successful treatment or is just an unwanted and unnecessary side effect.

Based on these concept, a photocoagulation technique was developed to treat the retina selectively (SRT - Selective retinal therapy), with minimal or no damage to the sensory layers. While the treatment is very similar to regular photocoagulation, the SRT laser uses much lower energy and very short pulses. As a result, treatment does not result in visible burns to the retina and previous studies have shown that the sensory layer remains intact.

The aim of this study is to determine the effect of SRT on the resolution of the edema.

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

32

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tel Aviv、以色列、64329
        • Tel Aviv Sourasky Medical Center
      • Tel Hahsomer、以色列、52621
        • Sheba medical center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Best corrected ETDRS visual acuity letter score >=24 (app. 20/320 or better)
  2. Definite retinal thickness due to diabetic macular edema by on clinical exam at or within 500 to 3000 microns of the macular center (radius) for which the investigator believes laser photocoagulation is not indicated
  3. A thickness equal or less than 315 microns in the central subfield (confirmed by SD-OCT).
  4. A thickness of >2 SD of norm in one or more inner or outer subfields on SD-OCT.
  5. Maximal focal/grid laser not yet applied (within areas of thickening between 500 and 3000 microns from center of macula, not all microaneurysms treated with direct laser and not all other areas of thickening treated with grid laser). Maximal or complete laser treatment is defined as direct treatment to all microaneurysms within areas of edema and grid treatment to all other areas of macular edema.
  6. No panretinal scatter photocoagulation (PRP) within prior 4 months.
  7. No recent medical treatment for DME (e.g., intravitreal/peribulbar steroids within past 4 months or intravitreal anti-VEGF injection within past 2 months).
  8. No major ocular surgery (including cataract extraction, any other intraocular surgery, scleral buckle, glaucoma filter, cornea transplant, etc.) within prior 6 months.
  9. No Nd:YAG laser capsulotomy within prior 2 months.
  10. Macular edema is not considered to be due to a cause other than diabetic macular edema

    o An eye should not be considered eligible (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or SD-OCT suggests that vitreoretinal interface disease (eg. vitreoretinal traction or epiretinal membrane) is the primary cause of the macular edema.

  11. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photos.
  12. No ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the first 12 months of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome).

    • Glaucoma per se is not an exclusion

Exclusion Criteria:

  1. History of renal failure requiring dialysis or renal transplant
  2. Condition that in the opinion of the investigator would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control)
  3. Patients in poor glycemic control who recently (>3 months) initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 3 months should not be enrolled.
  4. A patient with only one functioning eye (i.e., letter score 0 in contra-lateral eye)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:激光治疗
grid selective retinal treatment
其他名称:
  • SRT

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
progression of macular edema
大体时间:12months
Proportion progressing to center involved macular edema by month 12 as confirmed on SD-OCT
12months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Anat Loewenstein, MD、Tel-Aviv Sourasky Medical Center
  • 研究主任:Joseph Moisseiev, Prof.、Sheba medical center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年12月1日

初级完成 (实际的)

2015年6月1日

研究完成 (实际的)

2015年7月1日

研究注册日期

首次提交

2011年5月15日

首先提交符合 QC 标准的

2011年5月17日

首次发布 (估计)

2011年5月18日

研究记录更新

最后更新发布 (估计)

2016年9月7日

上次提交的符合 QC 标准的更新

2016年9月6日

最后验证

2016年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • LUM.NOVUS SRT.01

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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