A Phase IV, Randomised, Single Masked Study Investigating the Efficacy and Safety of Ranibizumab "Inject and Extend" Using an Intensive Retinal Fluid Retreatment Regimen Compared to a Relaxed Retinal Fluid Retreatment Regimen in Patients With Wet Age-related Macular Degeneration (AMD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 1
- 主要终点
- Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.
研究概览
简要总结
To evaluate and compare two individualised ranibizumab treatment regimens, differentiated by the definition of disease activity, which determines the treatment interval until the next injection. The results will be used to generate recommendations about ranibizumab treatment when using an 'inject and extend' approach to maximise patient outcomes, while reducing the need for potentially unnecessary intravitreal injections. This study will also investigate if genotypic expression influences response to intravitreal injections of ranibizumab between the two treatment arms.
The study hypothesis is that intravitreal ranibizumab when administered to resolve IRF (and/or SRF >200 μm at the foveal centre) results in visual acuity benefit that is not clinically worse than intravitreal ranibizumab when administered to completely resolve both IRF and SRF in patients with wet AMD
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
- Double (Participant, 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
- •Diagnosis of subfoveal CNV secondary to wet AMD without restriction of lesion size, with visual impairment being exclusively due to an active wet AMD lesion. Active lesions will be characterised by any of the following: abnormal retinal thickness, with evidence of intraretinal, subretinal or sub-pigment epithelial fluid accumulation, confirmed by OCT; presence of intraretinal or subretinal haemorrhage; new leakage shown on a FA; CNV enlargement on FA unless solely due to dry, fibrotic staining; visual acuity deterioration considered likely to represent CNV.
- •BCVA score at both Screening and Baseline must be 23 letters or more as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR charts (a Snellen visual acuity or equivalent of 20/320 or more may be used as an alternative at Screening).
排除标准
- •Any active periocular or ocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at the time of Screening or Baseline.
- •Uncontrolled glaucoma (intraocular pressure [IOP] ≥30 mm Hg on medication) at the time of Screening or Baseline.
- •Neovascularisation of the iris or neovascular glaucoma at the time of Screening or Baseline.
- •Visually significant cataract, aphakia, severe vitreous haemorrhage, rhegmatogenous retinal detachment, proliferative diabetic retinopathy or CNV of any cause other than wet AMD at the time of screening and baseline.
- •Structural damage within 0.5 disc diameter of the centre of the macula (e.g., vitreomacular traction, epiretinal membrane, scar, laser burn, foveal atrophy) at the time of screening that in the investigator's opinion could preclude visual function improvement with treatment.
- •Treatment with any anti-angiogenic drugs (including any anti-VEGF agents) prior to Baseline in study eye (allowed in fellow eye).
- •Any intraocular procedure (including Ytrium-Aluminium- Garnet capsulotomy) within 2 months prior to Baseline or anticipated within the next 6 months following Baseline in th study eye (allowed in fellow eye).
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Intensive retinal fluid regimen
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
干预措施: Ranibizumab (Drug)
Relaxed retinal fluid regimen
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.
时间窗: Baseline to month 24
Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 24.
次要结局
- Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF(Month 12 and 24)
- Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24(Months 12 and 24)
- Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.(Months 2, 12 and 24.)
- Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.(Baseline or following consent)
- The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months.(Month 24)
- Mean Change in BCVA From Baseline to Month 12.(Baseline to month 12)
- Mean Number of Injections From Baseline to Month 12 and 24(Baseline to month 12 to month 24.)
- Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24.(Baseline to months 12 and 24.)
- Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.(Baseline to month 12 and month 24)
- Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24.(Baseline to months 12 and 24.)
- Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24.(Baseline to months 12 and 24)