ISRCTN10012824进行中（未招募）3 期
A multicentre randomised controlled clinical trial testing the non-inferiority of a lighter to the standard initial dosing regimen of faricimab in patients with pretreated neovascular age-related macular degeneration
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 主要终点
- Change in best corrected visual acuity (BCVA) from baseline to an average of Week 52 and Week 56, as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a distance of 4 meters
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients aged 50 years or older
- •Patients must have macular neovascularization secondary to neovascular age-related macular degeneration (nAMD) in the study eye.
- •The study eye must have been previously treated with anti-angiogenic treatment (excluding faricimab) and undergone an initial induction phase of three monthly injections.
- •The study eye could not extend treatment interval beyond 12 weeks due to neovascular exudative activity, which includes intra- or submacular fluid, subretinal hyperreflective material (SHRM), or hemorrhage.
- •Best corrected visual acuity (BCVA) must be at least 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
- •Patients must have the ability and willingness to undertake all scheduled visits and assessments.
排除标准
- •Individuals who have not previously received anti-angiogenic treatment.
- •Prior administration of faricimab to the study eye.
- •Presence of fibrosis or atrophy in the central 1 mm of the ETDRS grid, active ocular inflammation, or infection in the study eye.
- •Tractional retinal detachment, preretinal fibrosis, or macular thickening secondary to an epiretinal membrane or vitreomacular traction affecting the macular architecture.
- •Any current or history of ocular disease other than nAMD that may confound assessment of the macula or affect central vision in the study eye.
- •Presence of uncontrolled glaucoma.
- •Any intraocular surgery within 3 months prior to randomization.
- •Females who are pregnant, breastfeeding, or intending to become pregnant during the study period.
- •Systolic blood pressure greater than 180 mmHg or diastolic pressure greater than 100 mmHg at rest.
- •History of stroke or myocardial infarction within the last 6 months.
- •Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the investigational drug or might affect interpretation of the results, or renders the patient at high risk for treatment complications.
结局指标
主要结局
Change in best corrected visual acuity (BCVA) from baseline to an average of Week 52 and Week 56, as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a distance of 4 meters
次要结局
- Measured at Baseline, Week 20 and Week 56:1. Efficacy on additional BCVA outcomes 2. Efficacy of anatomic outcome measures 3. Frequency of treatment administration 4. Safety outcomes 5. Patient-reported outcomes (PROs), including the visual function questionnaire 25 (VFQ25), EuroQol 5D (EQ5D), attitude towards injection burden
研究者
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