Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in drusen volume measured by Spectral Domain OCT
研究概览
简要总结
interventional trial for off label use of high dose atorvastatin 80 mg in intermediate AMD patients and correlate recovery response measured by dark adaptation recovery time with drusen volume reduction measured by SD-OCT
详细描述
Dark adaptation recovery time is a sensitive marker of AMD progression in intermediate AMD, largely owing to drusen volume providing a transport barrier that slows the transfer of nutrients between the choroid and photoreceptors2. Consequently, dark adaptation may provide an early indication of response vs. nonresponse, aiding case-by-case decisions on continuation of treatment when patients experience adverse side effects (e.g., elevated CPK or liver enzymes) or when atorvastatin provides insufficient lipid control in patients also at high-risk for cardiovascular disease (and switching to an alternative statin might be desirable).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects with intermediate AMD diagnosis in one or both eyes will be considered, regardless the severity stage and subtype of disease in the other eye.
- •High-risk iAMD (numerous large, confluent drusen covering ≥ 0.5 disk area, with or without pigmentary changes but having no evidence of GA or CNV) in the study eye
- •Subjects can have either:
- •(i) Bilateral high-risk iAMD, or (ii) High-risk iAMD in one eye with GA and/or CNV in the fellow eye.
排除标准
- •Patient previously taking high dose Atorvastatin 80 mg
- •Patients previously taking other statins than high dose atorvastatin, in whom primary care provider (PCP) feels cannot be safely moved to high dose atorvastatin or those in which high dose atorvastatin is deemed contraindicated by PCP
- •Patients with known adverse reaction to statins
- •Patients with severe renal disease or multiple comorbidities
- •Age >85 years
- •Pregnancy
- •Patients with concomitant use of cyclosporine
- •Active uveitis;
- •Ocular infection;
- •Any retinopathy other than AMD;
- •Media opacities;
- •Refractive error equal or superior to 6 diopters (spherical equivalent);
- •Any previous retina surgery;
- •Other ocular surgery or intra-ocular procedure in the study eye (injection other than anti angiogenic injection, laser) within the 90 days prior to enrollment
研究组 & 干预措施
Intermediate Age-Related macular degeneration patients
Subjects can have either:
- Bilateral high-risk iAMD
- High-risk iAMD in one eye with GA and/or CNV in the fellow eye No control arm
干预措施: Atorvastatin 80mg (Drug)
结局指标
主要结局
Change in drusen volume measured by Spectral Domain OCT
时间窗: 18 months
To measure and quantify improvement or positive response to high dose statin therapy in patients with intermediate AMD using drusen volume measured by SDOCT
Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT)
时间窗: 18 Months
Determine weather improvement in dark adaptation recovery time or rod intercept time (RIT) can be used as an early indicator of positive response to high dose statin therapy for intermediate AMD patients
To correlate visual functions of dark adaption with change in drusen volume
时间窗: 18 months
Patient will have Dark Adaptation testing performed to check change in vision function with changes in drusen volume.
次要结局
- To correlate change in microperimetry visual functional and retinal structural evaluation of study patients(18 months)
- To correlate change in contrast sensitivity and retinal structural evaluation of study patients(18 months)
- To correlate Best Corrected Visual Acuity and retinal structural evaluation of study patients(18 months)
研究者
John B. Miller, MD
Assistant Professor of Ophthalmology
Massachusetts Eye and Ear Infirmary