Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals Following 4 Loading Doses - Prospective Randomised Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in CRT
研究概览
简要总结
This is a prospective, randomized study that compares 8-week and 12-week follow-up intervals after the 4 monthly injections in the loading phase. Patients with active CNV confirmed on optical coherence tomography (OCT) and OCT angiography (OCTA) will be randomized into two groups and followed for 44 to 56 weeks.
Patients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks, followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks.
Patients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval. Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. The study will compare best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT, and the number of injections between both groups.
详细描述
Wet age-related macular degeneration (wet AMD) is a progressive eye disease that affects the macula, the part of the retina responsible for sharp central vision. The treatment of wet AMD choroidal neovascularization (CNV) with intravitreal antiVEGF drugs is highly effective. In our study, we aim to compare the efficacy of standard (8 weeks) versus extended follow-up dosing interval (12 weeks) following 4 monthly loading injections of the new combined-mechanism medication, faricimab (6 mg intravitreal dose), which targets both VEGF-A and Ang-2 receptors, in the treatment of wet AMD. We will include all types of CNVs in our study, including Type 1 (occult), Type 2 (classic), Type 3 CNV (Retinal Angiomatous Proliferation = RAP) and mixed CNV. This is a prospective, randomised, comparative study comparing the best corrected visual acuity (BCVA) and central retinal thickness (CRT) on optical coherence tomography (OCT) in the 20th, 24th week of the study between both groups. The total number of injections between both groups will be also compared at the final visit, which will take place between the 44th and 56th week of the study based on the dosing interval.
Patients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks (Week 20 Visit), followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks.
Patients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval (Week 24 Visit). Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. The study will compare best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT, and the number of injections between both groups.
Visit plan:
Screening visit - 14 to 0 day prior to baseline. Informed consent will be signed prior to any other study procedures. Ocular and medical history will be written down. BCVA of both eyes will be tested on ETDRS charts. Non-contact intraocular pressure (IOP) will be measured. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. The OCT scan of both eyes will be performed, and OCTA will be performed in the treatment naïve eyes. Based on the examination results, patients' eligibility for the study will be assessed.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active treatment naïve CNV (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed on OCT and OCTA
- •BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent) decrease in BCVA caused primarily by the CNV in the study eye
- •presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT
- •patient capable of signing the informed consent
排除标准
- •Myocardial Infarction or Stroke in the last 3 months
- •Previous or current conditions of the study eye:
- •subretinal haemorrhage comprising more than 25% of the lesion in the study eye
- •scar or fibrosis comprising more than 50% of the lesion in the study eye
- •presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
- •total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
- •uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
- •idiopathic or autoimmune uveitis in the study eye
- •other pathologies in the macula of the study eye unrelated to AMD which can be expected to influence the BCVA (e.g. macular hole, epiretinal membrane, etc.)
- •k. significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or OCT examination
- •n. diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye
- •o. extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit
- •p. any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
- •q. allergy or hypersensitivity to any component contained in the study drug
- •r. pregnant or breastfeeding women
研究组 & 干预措施
Group 2, 12-Week
Patients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval (Week 24 Visit). Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group.
干预措施: Faricimab Injection (Drug)
Group 1, 8-Week
Patients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks (Week 20 Visit), followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks.
干预措施: Faricimab Injection (Drug)
结局指标
主要结局
Change in CRT
时间窗: from baseline up to 56 weeks
Change in central subfield thickness (CST) over time as measured by SD-OCT
Patients with intraretinal or subretinal fluid or serous pigment epithelium detachment after loading
时间窗: From baseline to week 20 (Group 1) or week 24 (Group 2)
Number of patients with subretinal, intraretinal fluid or pigment epithelium detachment (PED) at week 20 (Group 1) or week 24 (Group 2)
次要结局
- Change from baseline in BCVA(From baseline up to 56 weeks)
- Presence of fluid(From baseline up to 56 weeks)
- Number of injections(From baseline up to 56 weeks)
- Treatment interval(From baseline up to 56 weeks)
研究者
Martin Pencak
Investigator
Faculty Hospital Kralovske Vinohrady