Photocoagulation of Capillary Macro-aneurysms in Addition to the Standard Treatment of Macular Edema Due to Diabetic Retinopathy. "TaLa_DME"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Number of anti VEGF injections
研究概览
简要总结
Our hypothesis is that implementing laser photocoagulation (IGTL) as an adjunctive treatment to intravitreal injections should lead to a significant reduction in the need for intravitreal injections in patients with diabetic macular edema without adverse consequences for visual acuity.
详细描述
This study will be French, multicenter parallel group, 2-arms, randomized, sham laser-controlled, double-blind trial evaluating the effect of IGTL as an adjunctive procedure to intravitreal injections in patients with DME.
Acts which are the subject of the study: indocyanine green-Guided Targeted Laser photocoagulation (IGTL): this combines routine procedures, that are, the detection of macro-aneurysms by ICG angiography, laser photocoagulation and optional post-laser verification of the effectiveness of the photothrombosis by OCT.
Study act: the treatment study includes a baseline laser treatment (experimental group) or sham laser (control group) at randomization, repeated if needed 3 month later, administered in combination with anti VEGF treatment, consisting of 3 monthly injections in the first 3 months, and a maintenance phase with monthly visits where retreatment is administered as needed through a PRN regimen, based on morphological (retinal thickness on OCT) and functional (visual acuity) criteria.
To evaluate the interest of IGTL in real conditions, the choice of the anti VEGF treatment used for intravitreal injection (Ranibizumab or Aflibercept, which have French marketing authorizations) is left to each investigator (equivalent therapeutic efficacy). Bevacizumab is ruled out due to its lower efficacy compared with Aflibercept among eyes with worse baseline VA, that represent the majority of the patients in our study. In addition, bevacizumab is currently off-label in France for DME If both eyes are eligible at the time of randomization, only one eye will be included and analyzed. However, the fellow eye will be treated with the randomization-assigned treatment and the testing will be performed on each eye.
Risks and constraints involved in the study: these procedures are commonly done in ophthalmology care settings; no additional risk is expected due to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •Diabetic women and men ≥18 years
- •with visual acuity lower or equal than 20/32 ( ≤ 74 TaLaDME protocol_v1.2_12.07.2018 9/76 ETDRS letters)
- •with central retinal thickness of more than 300μm in Spectral Domain OCT (SD-OCT) and/or presence of retro-foveal hard exudates
- •due to DME
- •with one or more macro-aneurysms with a diameter greater than 150 μm in the posterior pole
- •with health insurance
- •who signed the written informed consent form
排除标准
- •Presence of age-related drusens or of a macular degeneration in one or both any eyes
- •Significant opacity of the ocular media that could contribute to decreased visual acuity
- •macro-aneurysm(s) mainly responsible for the DME located less than 500μm from the center of the fovea (i.e. within 1 disc radius of the fovea),
- •Steroids injection within the last 4 months
- •proliferative diabetic retinopathy requiring panretinal photocoagulation or associated with posterior tractional retinal detachment that may be worsened by the use of anti-VEGF therapy
- •myocardial infarction or stroke within the last 3 months
- •Cataract surgery within the last 3 months
- •Local treatment with prostaglandin
- •Women who are pregnant, breast feeding or of child bearing age without effective contraception
研究组 & 干预措施
Experimental Group
Indocyanine green-Guided Targeted Laser photocoagulation combines routine procedures, that are, the detection of macro-aneurysms by ICG angiography, laser photocoagulation and optional post-laser verification of the effectiveness of the photothrombosis by OCT. Indocyanine green-Guided Targeted Laser photocoagulation is administered in combination with anti VEGF treatment
干预措施: Indocyanine green-Guided Targeted Laser photocoagulation (Procedure)
Control Group
Sham laser is administered at randomization visit and repeated if needed 3 month later in combination with anti VEGF treatment
干预措施: Sham laser (Procedure)
结局指标
主要结局
Number of anti VEGF injections
时间窗: 12months
as measured between baseline and M12
Change in Visual Acuity (Letters)
时间窗: 12 months
As measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)
次要结局
- Change in central macular thickness(12 months)
- Cost of treatment(12 months)
- Incremental cost-utility ratio(12 months)
- Impact on quality of life using standard score evolution(12 months)
- Number of AEs/SAEs(36 months)