Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients With Geographic Atrophy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in retinal pigment epithelium (RPE) thickness in the junctional zone
研究概览
简要总结
This study is a biomarker evaluation study in patients with geographic atrophy secondary to age-related macular degeneration (AMD). The study evaluates microperimetry (fundus-controlled perimetry) and optical coherence tomography imaging for assessing changes in retinal sensitivity and anatomy over time.
详细描述
The optical coherence tomography (OCT) and microperimetry biomarker evaluation in patients with GA (OMEGA) study aims to systematically compare a panel of established and novel visual function and structural outcome measures for monitoring GA progression. This prospective, natural-history study was performed at a tertiary referral center (University Hospital Basel, PI: Prof. Dr. med. Hendrik P.N. Scholl). The study included a baseline visit and follow-up visits at weeks 12, 24, and 48.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the study
- •Age >60 years
- •Ability (including a sufficient general health status according to investigators judgement) and willingness to undertake all scheduled visits and assessments including predefined methodology and standards utilizing microperimetry
- •GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in the study eye
- •GA lesion in the study eye must reside completely within the FAF imaging field (Field 2-30 degree image centered on the fovea)
- •BCVA of 20/63 or better (Snellen equivalent) using ETDRS charts at starting distance of 4 m in the study eye
- •Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active CNV in the study eye. The total GA lesion size >1.2 mm2 (approximately >0.5 disc area [DA]) and <17.78 mm2 (approximately <7 DA) and must reside completely within the FAF imaging field (Field 2, i.e., 30 degree image centered on the fovea). If GA is multifocal, at least 1 focal lesion must be >1.2 mm2 (approximately >0.5 DA).
- •Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging in the study eye.
排除标准
- •GA in either eye due to causes other than AMD (for example, monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies [e.g., chloroquine/hydroxychloroquine maculopathy])
- •Receiving active treatment in any studies of investigational drugs for GA/dry AMD in the study eye
- •Mean sensitivity difference > 3 dB between the two microperimetry examinations in the screening visit.
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- •Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy in the study eye
- •Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- •History of prophylactic subthreshold laser treatment for AMD in the study eye
- •Previous intravitreal drug delivery in the study eye (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti complement agents, or device implantation). A single intraoperative administration of a corticosteroid during cataract surgery for cystoid macular edema prophylaxis at least 3 months prior to screening is permitted.
- •RPE tear that involves the macula in either eye
- •Any concurrent ocular or intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could do either of the following:
- •Require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
- •If allowed to progress untreated, could likely contribute to loss of at least two Snellen equivalent lines of BCVA during the study period
- •Previous violation of the posterior capsule in the study eye unless it occurred as a result of Yttrium Aluminum Garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation
结局指标
主要结局
Change in retinal pigment epithelium (RPE) thickness in the junctional zone
时间窗: Week 12
Change from baseline in retinal pigment epithelium (RPE) layer thickness in the junctional zone and in the perilesional zone measured by OCT
Change in photoreceptor thickness in the junctional zone
时间窗: Week 12
Change from baseline in photoreceptor layer thickness in the junctional zone and in the perilesional zone measured by OCT
Change in retinal sensitivity in the junctional zone
时间窗: Week 12
Change from baseline in retinal sensitivity in the junctional zone and in the perilesional zone of the largest atrophic loci as assessed by microperimetry
次要结局
未报告次要终点