EUCTR2013-003320-36-IT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
- 320
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
- 性别
- All
入选标准
- •Male or female patients 55 years of age or older as assessed at Screening Visit 1
- •Diagnosis of non-central 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:
- •- Located outside a 300 micron radius from the center point of the fovea (ie, noncentral
- •atrophic lesions)
- •- At least one focal lesion must be equal to or larger than 0.3 mm2
- •- The total lesion area must be greater than 1.25 mm2, but not larger than 12.5 mm2
- •- Lesions must occupy 50% or less of the area of the retina between a 0.5 mm radius
- •and a 1.5 mm radius from the foveal center point (lesions that occupy more than 50%
- •of this area will limit the area available for retinal sensitivity assessment)
- •- 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 500 µm
- •The Study Eye must have:
- •- Presence of reticular drusen (also known as reticular pseudodrusen, subretinal drusenoid
- •deposits, reticular macular disease); a minimum of 5 individual lesions assessed with near
- •infrared reflectance (macular IR-image acquired with the SD-OCT scan); based on images collected at Screening Visit 1 and
- •confirmed by the CRC
- •- BCVA better than or equal to 59 letters (20/62 Snellen equivalent) at Screening Visit 1, Screening Visit 2
- •and the Baseline visit as assessed using the standard ETDRS (Early Treatment of
- •Diabetic Retinopathy Study) visual acuity protocol
- •- Ability to complete repeat assessments of scotopic microperimetry with an intra-visit,
- •mean, retinal sensitivity reproducibility of 3 dB or less, as assessed at Screening Visit 2
- •- Clear ocular media and adequate pupil dilation to permit good quality retinal imaging as
- •assessed at Screening Visit 1 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
- •Diagnosis of central GA, unifocal atrophic lesions, or lesions with no perilesional hyperautofluorescence,
- •or with only focal areas of perilesional hyper-autofluorescence on FAF examination of the study eye at Screening Visit 1
- •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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