Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 608
- 试验地点
- 1
- 主要终点
- Functional and morphological improvement in DME after initial therapeutic loading phase, according to ESASO stage of progression of the disease.
研究概览
简要总结
Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification.
详细描述
The ESASO morphologic classification of diabetic macular edema defines four stages of progression of the disease: early, advanced, chronic and atrophic maculopathy.
This grading is generated by the analysis of seven biomarkers that fully describe the level of retinal damage. Aim of this classification is to be a valid method for a comprehensive description of DME in scientific studies or clinical practice.
Given the recent publication of ESASO Classification, there aren't observations on the real relevance of grading DME on therapeutic outcome.
This retrospective study wants to give a preliminary answer to this important issue.
As a corollary outcome, this study will also evaluate the concordance of grading among participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Past ocular surgery of any kind (except for cataract surgery) or ocular pathologies other than diabetic retinopathy.
- •Macular edema considered to be due to a cause other than diabetic macular edema.
- •OCT examination suggesting that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema. In the case of ERM, an OCT scan must be sent to the Coordinating Center for approval.
- •Any ocular pathology or ocular condition other than diabetes that in the opinion of the investigator might affect macular edema.
- •History of any therapy (anti-VEGF treatment, focal/grid macular photocoagulation, intravitreous or peribulbar corticosteroids) for DME or diabetic retinopathy in the past 8 months.
- •History of YAG capsulotomy performed within two months before enrollment.
研究组 & 干预措施
Early DME
Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately
干预措施: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone (Drug)
Advanced DME
Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately
干预措施: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone (Drug)
Severe DME
Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately
干预措施: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone (Drug)
Atrophic diabetic maculopathy
Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately
干预措施: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone (Drug)
结局指标
主要结局
Functional and morphological improvement in DME after initial therapeutic loading phase, according to ESASO stage of progression of the disease.
时间窗: Four months
Visual acuity and morphological (OCT) stage of the disease (as described in ESASO DME classification) will be evaluated at time 0 and four months after the first injection of intravitreal dexamethasone or one month after the loading phase (3 monthly injections) with anti-VEGF.
次要结局
- Validation of ESASO DME staging classification(3 months)