EUCTR2013-003320-36-DE进行中（未招募）1 期
Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON Study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Male or female patients 55 years of age or older as assessed at Screening Visit 1
- •The study eye must have:
- •Diagnosis of GA secondary to AMD, as assessed with fundus autofluorescence (FAF) at Screening Visit 1 and confirmed by the central reading center (CRC); these atrophic areas consist of funduscopically visible discrete areas characterized by a marked decrease in fundus autofluorescence intensity and loss of outer-retinal layers with choroidal signal enhancement as assessed with SD-OCT.
- •Areas of atrophy must be multifocal lesions that contain all of the following characteristics:
- •- At least one focal lesion must be equal to or larger than 0.2 mm2
- •- The total lesion area must be greater than 1.25 mm2, but not larger than 18 mm2
- •- The presence of banded or diffuse perilesional hyper-autofluorescence evident on fundus autofluorescence examination.
- •- The distance between the optic disc or peripapillary atrophy and any atrophic lesion must be greater than 300 µm
- •Presence of drusen, yellow or white accumulations of extracellular material formed between Bruch's membrane and the retina pigmented epithelial cell layer, assessed with fundus photography and/or SD-OCT at Screening Visit 1 and confirmed by the CRC
- •- BCVA better than or equal to 45 letters (20/125 Snellen equivalent) at Screening Visit 1 and the Baseline visit as assessed using the standard ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity protocol
- •- Clear ocular media and adequate pupil dilation to permit good quality retinal imaging as assessed at Screening Visit 1 and confirmed by the CRC
- •- For patients participating in microperimetry assessments: abitity to complete repeat assessments of scotopic/mesopic microperimetry with an intra-visit, mean, retinal sensitivity reproducibility of 6 dB or less, as assessed at Screening Visit 2 and confirmed by the CRC
- •The Fellow Eye must have Standard BCVA of 34 letters (Snellen equivalent 20/200) or better at Screening Visit 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •History or evidence of choroidal neovascularization in either eye at Screening Visit 1, as confirmed by the CRC
- •Diagnosis of GA secondary to AMD that presents as unifocal atrophic lesions, lesions with no perilesional hyper-autofluorescence, lesions with only focal areas of perilesional hyper-autofluorescence on FAF examination of the study eye at Screening Visit 1 and confirmed by the CRC
- •Spherical equivalent of the refractive error of -6 diopters of myopia or worse (prior to cataract or refractive surgery) in the study eye at Screening Visit 1
研究者
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