NCT06769048进行中（未招募）2 期
JADE: Phase II Trial in Patients With Geographic Atrophy: A Randomized, Double-masked, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of BI 1584862
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 44
- 主要终点
- Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) over a treatment period of up to 50 weeks (expressed in mm/year) in the study eye
研究概览
简要总结
This study is open to adults aged 50 years and older with geographic atrophy that was diagnosed by imaging of the retina. The purpose of this study is to find out whether a medicine called BI 1584862 improves the eyes in people with geographic atrophy and to find the most suitable dose.
This study has 4 treatment groups. Participants are put into groups randomly, which means by chance. Initially participants can join a BI 1584862 and a placebo group; then more participants are put randomly in 2 additional BI 1584862 groups and a placebo group.
Participants are in the study for 1 year. During this time, they visit the study site 13 times. At the visits, doctors check the severity of participants' eye disease and collect information on any health problems. They take detailed pictures of the back of the eye, the retina, with imaging methods called fundus autofluorescence (FAF), near-infrared reflectance (NIR), and optical coherence tomography (OCT). They measure areas of the retina that appear healthy (bright) or start to waste away (dark, atrophy). The changes over time are then compared between the treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men and women with at least 1 eye with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) determined by fundus autofluorescence (FAF). The total size of all GA lesions in the study eye (as determined by the independent central reading center (CRC)) must be ≥1.25 mm^2 and ≤12.0 mm^2:
- •If multiple lesions are present in the study eye, at least 1 lesion must have an area of ≥0.5 mm^2
- •At least 1 GA lesion must be at least in part within a 1500 μm radius ring centered on the fovea
- •The foveal center point must not be involved in any atrophic lesion
- •Lesion(s) must reside completely within the FAF image
- •Best corrected visual acuity (BCVA) score of ≥50 letters in the study eye using the early treatment diabetic retinopathy study (ETDRS) chart (approximately equivalent to ≥20/100 on the Snellen chart).
- •Hyperautofluorescence of any pattern, as assessed by the CRC, must be present in the junctional zone of GA in the study eye.
- •Age ≥50 years.
- •Men must be willing and able to use contraception (condom, abstinence) to prevent pregnancy and/or exposure of an existing embryo or fetus to the investigational product. A female participant is eligible if she is not a woman of childbearing potential.
- •Signed informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH GCP) guidelines and local legislation
排除标准
- •Any history of, or evidence of, exudative age-related macular degeneration (eAMD) in the study eye.
- •Previously received treatment for GA in the study eye within 4 months or 5 half-lives, prior to baseline, whichever is longer.
- •Previously received an investigational medication (oral or intravitreal) for GA within 4 months or 5 half-lives prior to baseline, whichever is longer.
- •Additional eye disease in the study eye that could compromise BCVA or significantly impact retinal morphology:
- •uncontrolled glaucoma, defined as a disk-to-cup ratio >0.8 or ocular hypertension with intra ocular pressure (IOP) >24 mmHg at screening visit, or use of >2 active IOP-lowering agents in the study eye
- •clinically significant diabetic retinopathy or maculopathy in the opinion of the investigator
- •history of high myopia, i.e. spherical equivalent of ≥8 diopters or axial length ≥27.2 mm. Note: if subject had prior cataract or refractive surgery, spherical equivalent should be evaluated with pre-operative refraction. If axial length measurement is not available in medical records and cannot be obtained at screening visit, assessment of high myopia can be made by investigator on clinical examination.
- •anterior segment and vitreous abnormalities that would preclude adequate observation with SD-OCT in the opinion of the investigator
- •other ocular conditions at the discretion of the investigator that might interfere with the outcome of the trial
- •Significant disease or other medical conditions (as determined by medical history, examination, and clinical investigations at screening) that may, in the opinion of the investigator result in any of the following:
- •put the participant at risk because of participation in the study
- •influence the results of the study
- •cause concern regarding the participant's ability to comply with the protocol requirements or complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the participant an unreliable trial participant)
- •Known hypersensitivity to any of the ingredients used in the investigational medicinal product (IMP) formulation, or any of the medications used.
- •Active intraocular inflammation in the study eye.
- •Active infectious conjunctivitis in either eye. Further exclusion criteria apply.
研究组 & 干预措施
BI 1584862 dose 3
Experimental
干预措施: BI 1584862 (Drug)
BI 1584862 dose 1
Experimental
干预措施: BI 1584862 (Drug)
BI 1584862 dose 2
Experimental
干预措施: BI 1584862 (Drug)
Placebo-matching BI 1584862
Placebo Comparator
干预措施: Placebo-matching BI 1584862 (Drug)
结局指标
主要结局
Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) over a treatment period of up to 50 weeks (expressed in mm/year) in the study eye
时间窗: Up to week 50.
mm is millimeters.
次要结局
- Change from baseline in partial attenuation as a percentage of the ellipsoid zone (EZ) at the macular area with thickness <20 micrograms (μm) up to week 50 assessed by volumetric optical coherence tomography (OCT) in the study eye(Up to week 50.)
- Change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) at Week 50 (expressed in mm) in the study eye(At baseline and at week 50.)
- Occurrence of BCVA letter loss of ≥15 from baseline in the study eye as measured by standardized ETDRS chart for at least 2 consecutive visits between baseline and up to Week 50(Up to week 50.)
- Change from baseline in best-corrected low luminance visual deficit (LLVD) score as measured in letters by ETDRS chart under low-luminance conditions at Week 50 in the study eye(At baseline and at week 50.)
- Key secondary endpoint: Change from baseline in total attenuation as a percentage of the EZ at the macular area with a thickness of 0 μm up to week 50 assessed by volumetric OCT and EZ mapping in the study eye(Up to week 50.)
- Occurrence of TEAES from drug administration until Week 52(Up to week 52.)
- Change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) at Week 50 (expressed in mm) in the study eye(At baseline and at week 50.)
- Key secondary endpoint: Slope of change from baseline in square root transformed GA area as measured by OCT over a trial period of up to 50 weeks (expressed in mm/year) in the study eye(Up to week 50.)
- Change from baseline in partial attenuation as a percentage of the ellipsoid zone (EZ) at the macular area with thickness <20 micrograms (μm) up to week 50 assessed by volumetric optical coherence tomography (OCT) in the study eye(Up to week 50.)
- Occurrence of BCVA letter loss of ≥15 from baseline in the study eye as measured by standardized ETDRS chart for at least 2 consecutive visits between baseline and up to Week 50(Up to week 50.)
- Change from baseline in best-corrected low luminance visual deficit (LLVD) score as measured in letters by ETDRS chart under low-luminance conditions at Week 50 in the study eye(At baseline and at week 50.)
研究者
研究点 (44)
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