NCT06722157进行中（未招募）2 期
Randomized, Double-masked, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of Two Regimens of Intravitreal BI 771716 Against Pegcetacoplan in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration VERDANT Trial
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
- 202
- 试验地点
- 92
- 主要终点
- Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) in the study eye expressed in millimeter (mm)/year
研究概览
简要总结
This study is open to people 50 years or older with an eye condition called geographic atrophy. The purpose of this study is to compare a medicine called BI 771716 with a medicine called pegcetacoplan. BI 771716 is being developed to treat people with geographic atrophy. Pegcetacoplan is a medicine already used to treat people with geographic atrophy.
In this study, participants receive either BI 771716 or pegcetacoplan as injections in the eye.
Participants are in the study for a little longer than a year and visit the study site every 4 weeks. At the visits, the study doctor checks the eyes of the participants. The results are compared between the groups of participants to see whether the treatment works. The study doctor also regularly checks participants' health and takes note of any unwanted effects.
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
- •Age at least 50 years old at the time of randomization visit
- •Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use are provided in the participant information. Male participants must be ready and able to use either a condom or abstinence as contraceptive measures
- •Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), where the total GA lesion area must be ≥2.5 square millimetres (mm²) and ≤17.5 mm² as measured by Fundus autofluorescence (FAF)
- •If multiple lesions are present in the study eye, at least 1 lesion must have an area of ≥1.25 mm²
- •Note: Fellow eye is not required to have GA
- •Note: subfoveal GA lesions (defined as GA lesions within 1 micron of the foveal center point) will be allowed to be enrolled until a maximum of approximately 60% of participants with subfoveal GA lesions are enrolled. Participants with subfoveal GA lesions already in screening at the time the cap has been reached may be considered for randomization.
- •Fellow eye must have sufficient visual function compared to the study eye, per the investigator's medical judgment in consultation with the patient, to support the patient's daily functioning
- •BCVA letter score of ≥24 letters, using the ETDRS chart in the study eye (equivalent to ≥20/320 on the Snellen chart). Note: If both eyes meet eligibility criteria, the eye with the worse visual function per the investigator's medical judgment in consultation with the patient, will be selected as the study eye. If both eyes have similar visual function, the study eye will be selected per the investigator's medical judgment in consultation with the patient
- •further inclusion criteria apply
排除标准
- •GA lesions whose area cannot be accurately defined in the study eye
- •Exudative neovascular AMD (eAMD) in the study eye
- •-- Note: eAMD in the fellow eye is allowed. However, if the fellow eye is to be considered for microperimetry and other analyses (as defined in the trial statistical analysis plan), then eAMD is not allowed in either eye.
- •Previously received treatment in the study eye for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer
- •Previously received an investigational medication (oral or intravitreal) for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer
- •Currently enrolled in another investigational device or drug trial, or 30 days or 5 half-lives, whichever is longer since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Any previous use of gene therapy or cell therapy is not permitted
- •Additional eye disease as follows:
- •Any eye disease in the study eye that could compromise BCVA
- •Uncontrolled glaucoma or ocular hypertension with intraocular pressure >24 millimetre of mercury (mmHg) in study eye
- •History of high myopia >8 diopters in the study eye
- •Anterior segment and vitreous abnormalities that would preclude adequate observation with spectral domain optical coherence tomography in the study eye
- •Ocular conditions at the discretion of the investigator that might interfere with outcome of the trial in the study eye
- •Active intraocular inflammation in the study eye
- •Active infectious conjunctivitis in either eye
- •Prior vitrectomy surgery in the study eye
- •History of major intraocular surgeries including major corneal surgery. Uneventful cataract surgery, refractive surgery, oculoplastic surgery, strabismus surgery, and other extraocular surgery may be permitted if they have occurred more than 3 months prior to baseline in the study eye
- •further exclusion criteria apply
研究组 & 干预措施
Arm B: BI 771716 and Sham comparator
Experimental
干预措施: Sham comparator to BI 771716 (Drug)
Arm C: Pegcetacoplan
Active Comparator
干预措施: Pegcetacoplan (Drug)
Arm B: BI 771716 and Sham comparator
Experimental
干预措施: BI 771716 (Drug)
Arm A: BI 771716
Experimental
干预措施: BI 771716 (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) in the study eye expressed in millimeter (mm)/year
时间窗: At Baseline , at Week 56
次要结局
- Change from baseline in square root transformed GA area as measured by FAF in the study eye expressed in mm(At Baseline, at Week 56)
- Change from baseline in best corrected visual acuity (BCVA) as measured by standardized early trial diabetic retinopathy study (ETDRS) chart in the study eye(At Baseline, at Week 56)
- Occurrence of BCVA letter loss of ≥15 letters as measured by standardized ETDRS chart in the study eye for at least 2 consecutive visits(Up to Week 56)
- Occurrence of exudative neovascular age-related macular degeneration (eAMD) in the study eye from first drug administration until Week 56(Up to Week 56)
- Occurrence of drug-related adverse events (AE) from first drug administration until Week 56(Up to Week 56)
研究者
研究点 (92)
Loading locations...
相似试验
已完成
2 期
A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic AtrophyGeographic AtrophyNCT04656561Annexon, Inc.270
已完成
2 期
A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)Geographic AtrophyNCT05811351Janssen Research & Development, LLC305
终止
2 期
Intravitreal Injections of Sirolimus in the Treatment of Geographic AtrophyGeographic AtrophyNCT01675947National Eye Institute (NEI)52
已完成
不适用
Investigation of geographic atrophy for eye disease patient1.Typical age-related macular degenration 2.Polypoidal choroidal vasculopathy 3.Retinal angiomatous proliferation 4.Central serous chorioretinopathy 5.Idiopathic macular telangiectasiaJPRN-UMIN000009625Kagawa University200
终止
1 期
A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic AtrophyMacular DegenerationNCT04002310Boehringer Ingelheim18