Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation of systemic factors on functional and anatomical outcome at month 6.
研究概览
简要总结
This study aims to evaluate the influence and prognostic value of systemic factors (such as the cardiovascular and metabolic status) on the treatment response to anti-VEGF therapy in macular edema due to diabetes or retinal vein occlusion.
详细描述
This study includes patients with macular edema (ME) due to diabetes or retinal vein occlusion in the need of treatment.
At baseline patients underwent an extensive ophthalmological examination (best-corrected visual acuity, OCT, OCT-angiography, fluorescein angiography, fundus photography). Besides that, systemic work-up (including 24h blood pressure measurement, electrocardiogram, and serological blood testing) is conducted.
Patients underwent routine ME treatment including at least 4 monthly anti-VEGF injections, as first-line therapy. Further injections will be conducted if needed. Re-treatment criteria are: persistent intra- and/or subretinal fluid seen on SD-OCT, central subfield thickness > 300 µm. Ophthalmological examination will be repeated at month 3, 6 and month 12. Systemic work-up will be repeated at month 6.
Primary outcome is the correlation of systemic parameters with functional and anatomical response at month 6. Secondary outcome is the correlation of systemic parameters with functional and anatomical response at month 12.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of diabetes mellitus (type 1 or type 2) and/or retinal vein occlusion
- •macular edema causing visual loss, with study eye VA of 0.1 - 1.0 logMAR (20/25 - 20/200 Snellen equivalent)
- •macular edema defined clinically and by retinal thickness of > 300 µm in the central subfield thickness (CST) with intra +/- subretinal fluid seen on spectral domain optical coherence tomography
- •last intravitreal treatment > 3 months ago.
排除标准
- •concomitant ocular disease that could cause macular edema (including choroidal neovascularization from any cause, uveitis or intraocular surgery less than 6 months ago).
- •any concomitant ocular or neurological condition that could affect Vision except of cataract.
研究组 & 干预措施
Patient with Macular edema
Patients with clinically significant macular edema due to diabetes or retinal vein occlusion, undergoing at least 4 monthly intravitreal anti-VEGF injections.
干预措施: Anti-VEGF (Drug)
结局指标
主要结局
Correlation of systemic factors on functional and anatomical outcome at month 6.
时间窗: 6 months
Correlation between blood pressure and serological Parameters at baseline and visual acuity/central subfield thickness at month 6.
次要结局
- Correlation of systemic factors on functional and anatomical outcome at month 12.(12 months)
研究者
PD Dr. habil. Matus Rehak
Prof. MUDr. Matus Rehak
University of Leipzig