Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Retinal thickness change
研究概览
简要总结
Prospective, non-comparative, mono-center pilot study. Patients with neovascular age-related macular degeneration (nAMD), responding insufficiently to the maximal standard care with monthly intravitreal anti-VEGF injections are given adjuvant oral mineralocorticoid receptor antagonists for 4 months and observed for any changes in vision or retinal structure during the 4 months of adjuvant treatment, plus 2 additional months without adjuvant treatment.
详细描述
Hypothesis Systemic anti-Mineralocorticoid-Receptor treatment may be a valuable adjuvant treatment in anti-VEGF refractory nAMD, potentially allowing for better absorption of the exudative fluid.
Aim To estimate the effect of systemic anti-Mineralocorticoid-Receptor treatment on eyes with nAMD which have remained exudative despite monthly anti-VEGF treatment for at least 6 months prior to enrolment.
Objectives Primary objective
-
To calculate the changes induced in retinal thickness following adjunct systemic anti-Mineralocorticoid-Receptor treatment Secondary objective
-
To calculate the changes induced following adjunct systemic anti-Mineralocorticoid-Receptor treatment in the following ocular parameters
-
Thickness of the neuro-retina (foveal)
-
Amount of subretinal fluid (foveal and highest elevation)
-
Height of retinal pigment epithelium detachment (foveal and highest elevation)
-
Central (Subfoveal) choroidal thickness, and at 500um nasal and temporal to the fovea
-
Presence / absence of exudative signs on OCT, according to the type of fluid (intraretinal cysts, subretinal fluid)
-
Best corrected visual acuity (number of letters)
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of neovascular age-related macular degeneration, as confirmed on angiography by a retinal specialist (IM or AA)
- •Aged more than 50 years (inherent to AMD)
- •Unresponsive to maximal (monthly) anti-VEFG treatment (Ranibizumab or Aflibercept) for at least 6 months: persistant intra- or subretinal fluid on spectral domain optical coherence tomography at each visit 1 month after last injection.
- •Treatment with anti-VEGF for nAMD for at least 12 months
- •No contra-indications for adjunctive Spironolactone treatment
排除标准
- •Confounding retinal pathology eg. myopic chorioretinopathy, diabetic retinopathy, vascular occlusion, retinal dystrophy and other retinal pathology
- •Polypoidal choroidal vasculopathy
- •Vitreomacular traction
- •Poor quality OCT (image quality does not allow the grading / measures on OCT)
- •High arterial pressure (>160/100)
- •K+>5.0 mmol/l at baseline
- •Na+ <135 mmol/l at baseline
- •Creatinine clearance under 30mL/min (calculation : coefficient*(140-age)*weight/creatinine in the serum; coefficient = 1.23 for males and 1.04 for females)
- •Acute renal failure
- •Renal dialysis
- •Non-specified renal problem
- •Arrhythmia
- •Cardiovascular comorbidity with thromboembolic risk
- •Known hypersensitivity to Spironolactone
- •Ongoing medication with eplerenone (Inspra®)
- •Decompensated hepatic cirrhosis
研究组 & 干预措施
Single treatment arm
干预措施: Spironolactone 50 MG (Drug)
结局指标
主要结局
Retinal thickness change
时间窗: Month 3, Month 6
retinal thickness in micrometers measured from the internal limiting membrane (ILM) to Bruch's membrane on optical coherence tomography
次要结局
- central retinal volume(Month 3, Month 6)
- pigment epithelium detachment height(Month 3, Month 6)
- subfoveal choroidal thickness(Month 3, Month 6)
- Best-corrected visual acuity(Month 3, Month 6)
- central retinal thickness(Month 3, Month 6)
- subretinal fluid thickness(Month 3, Month 6)
- maximum neuroretinal thickness with cystic changes(Month 3, Month 6)
- foveal retinal thickness(Month 3, Month 6)
研究者
Dr Irmela MANTEL
lead consultant, Head of the medical retina service, Principal Investigator, Privatdocent
Eye Hospital Jules Gonin