Intravitreal Faricimab in Diabetic Macular Edema With Limited Response to Aflibercept
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- maximum treatment interval with intravitreal faricimab at month 12.
研究概览
简要总结
Title: Intravitreal faricimab in diabetic macular edema with limited response to aflibercept
Purpose: The purpose of this investigator initiated study is to identify the effects of intravitreal faricimab on recurrence-free treatment intervals and morphological features in diabetic macular edema (DME) in which the Optical coherence tomography (OCT) guided treatment interval failed to be extended to 6 weeks intervals in a treat and extend regimen using aflibercept.
Objectives: The primary objective is to evaluate the proportion of patients with an increased maximum treatment interval with intravitreal faricimab (compared to previous 4-week interval under aflibercept) in an OCT guided treat and extend regimen at month 6 and 12. (for further outcome measures see section Objectives)
详细描述
Title: Intravitreal faricimab in diabetic macular edema with limited response to aflibercept
Study purpose: The purpose of this investigator initiated study is to identify the effects of intravitreal faricimab on recurrence-free treatment intervals and morphological features in diabetic macular edema (DME) in which the Optical coherence tomography (OCT) guided treatment interval failed to be extended to 6 weeks intervals in a treat and extend regimen using aflibercept.
Objectives: The primary objective is to evaluate the proportion of patients with an increased maximum treatment interval with intravitreal faricimab (compared to previous 4-week interval under aflibercept) in an OCT guided treat and extend regimen at month 6 and 12.
The secondary objectives are:
- The mean maximum treatment interval with intravitreal faricimab at month 6 and 12.
- The number of treatments applied during the 12 months study period.
- The mean change in BCVA (Best Corrected Visual Acuity) from baseline (=switch to faricimab) to month 6 and 12.
- To compare the mean BCVA at baseline (=switch to faricimab) and month 6/12 in patients with extended treatment intervals under faricimab.
- The mean change in CS (Contrast Sensitivity) from baseline (=switch to faricimab) to month 6 and 12.
- The mean change in AllEye index (metamorphopsia index) from baseline (=switch to faricimab) to month 6 and 12.
- The mean change in central retinal thickness as measured in the central ETDRS ( Early Treatment Diabetic Retinopathy Study) subfield from baseline (=switch to faricimab) to month 6 and 12.
- To compare the incidence of qualitative OCT features like intraretinal fluid, subretinal fluid, and hyperreflective foci between baseline (=switch to faricimab) and month 6 and 12.
- Percentage of patients achieving a dry retina at month 6 and 12.
- The mean changes in FAZ (foveal avascular zone) area and vessel density as measured by OCT-Angiography (OCTA) from baseline (=switch to faricimab) to month 6 and 12.
- The change in quality of life (VFQ-25 scores) from baseline to 6 and 12 months.
- To evaluate the safety and tolerability of up to 4weekly dosing of faricimab in DME by determining the rates of adverse events and serious adverse events at 6 and 12 month
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 years of age and documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- •Patients with diagnosis of diabetic macular edema (DME).
- •Pre-treatment with intravitreal aflibercept in a treat and extend regimen and failing to be extended from the minimum interval of 4 weeks by two weeks to a 6-weeks interval without recurring DME activity or showing persisting DME activity in all visits under 4-weekly aflibercept treatment for at least 6 months.
- •Patients who have a Best corrected Visual Acuity (BCVA) of at least 20/160 (letter score 40 letters) in the study eye using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.
- •Willing and able to give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure including withdrawal from exclusionary medications for the purpose of this study.
- •Willing and able to comply with study procedures.
- •For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
排除标准
- •Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
- •Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
- •Prior administration of intravitreal faricimab in either eye
- •Active intraocular or periocular infection or active intraocular inflammation in the study eye
- •Any history of ocular disease other than DME that may confound assessment of the macula/ affect central vision in the study eye
- •History of uncontrolled glaucoma in the study eye (intraocular pressure ≥25 mmHg despite anti-glaucoma medication).
- •Aphakia with absence of the posterior capsule in the study eye.
- •Extracapsular extraction of cataract with phacoemulsification within three months preceding Baseline, or a history of post-operative complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis, etc.).
- •Use of other investigational drugs at the time of baseline, or within 30 days or 5 half- lives of baseline, whichever is longer (excluding vitamins and minerals).
- •Previous violation of the posterior capsule in the study eye unless as a result of laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
- •Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day
- •Uncontrolled blood pressure (systolic value >180 mmHg and/or a diastolic value >100 mmHg while the patient is at rest)
- •Currently pregnant or breastfeeding, or intend to become pregnant during the study.
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
- •History of hypersensitivity or allergy to fluorescein.
- •Inability to obtain Optical Coherence Tomography (OCT), Optical Coherence Tomography Angiography (OCTA), fundus photographs or fluorescein angiograms of sufficient quality.
研究组 & 干预措施
Vabysmo (Faricimab) 6 mg
Vabysmo (Faricimab) 6 mg solution for intravitreal injection All consenting, enrolled patients will receive an intravitreal injection of faricimab 6 mg at baseline (week 0), at week 4, 8, 12 (=4x loading) and each of the following treat and extend visits up to month 12.
干预措施: FARICIMAB 6 Mg in 0.05 mL INTRAVITREAL INJECTION, SOLUTION [VABYSMO] (Drug)
结局指标
主要结局
maximum treatment interval with intravitreal faricimab at month 12.
时间窗: 12 months
maximum treatment interval with intravitreal faricimab at month 12.
次要结局
- Subretinal fluid(12 months)
- CRT (Central retinal thickness)(12 months)
- VFQ-25 Quality of Life Score(12 months)
- BCVA(12 months)
- metamorphopsia index(12 months)
- Contrast Sensitivity (CS) threshold(12 months)
- injection number(12 months)
- Contrast acuity (CA)(12 months)
- Intraretinal fluid(12 months)
- Hyperreflective foci(12 months)
- FAZ (foveal avascular zone) area(12 months)
- Vessel density (VD)(12 months)
- Adverse events(12 months)
研究者
PD Dr. med. Katja Hatz
Head of clinical research and medical retina
Vista Klinik