The Effect of Intravitreal Faricimab in Patients With Refractory Macular Edema and Refractory Age Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- central retinal thickness
研究概览
简要总结
This prospective study will include about 40 patients with resistant wet age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion edema (RVO) edema.The inclusion criteria are that all patients must be 40 years old or older, diagnosed with active wet AMD or macular edema due to RVO or DME, and have received at least four previous monthly injections of anti-VEGF other than faricimab. All patients will be switched to receive four loading doses of intravitreal faricimab (6 mg) at 4-week intervals for four months. The response to faricimab will be assessed regarding visual acuity and central macular thickness.
详细描述
This prospective study will include about 40 patients with resistant wet age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion edema (RVO) edema.
The inclusion criteria are that all patients must be 40 years old or older, diagnosed with active wet AMD or macular edema due to RVO or DME, and have received at least four previous monthly injections of anti-VEGF other than faricimab.
All patients will be switched to receive four loading doses of intravitreal faricimab (6 mg) at 4-week intervals for four months. The response to faricimab will be assessed regarding visual acuity (functionally), central macular thickness, and the presence of subretinal or intraretinal fluid (anatomically) by optical coherence tomography OCT and compared with pre-injection visual acuity and OCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 45 years or older
- •DME, RVO edema, or wet-AMD diagnosed by clinical evidence and optical coherence tomography angiography (OCTA).
- •Previously treated with:
- •At least six doses of Avastin in DME or RVO edema cases or 3 dose of Avastin in AMD cases in the last year.
- •At least five doses of Eylea in DME or RVO edema cases or 3 dose of Eylea in AMD cases in the last year.
- •Lack of significant anatomical or visual improvement (i.e., primary non-responders)
- •Willingness and ability to attend follow-up appointments and comply with treatment protocol.
排除标准
- •Inconsistent treatment history: missed a dose of anti-VEGF doses, or incomplete the three loading doses of Faricimab.
- •Ocular comorbidities that could confound outcomes, such as:
- •Visually significant cataract as Grade 3+ or more.
- •Corneal opacity.
- •Uncontrolled glaucoma (IOP > 25 mmHg on meds) with an increase in cup/disc ratio.
- •Other macular pathologies (e.g., macular hole, epiretinal membrane ERM)
- •Severe baseline vision loss (BCVA < 6/60).
研究组 & 干预措施
faricimab
Eligible participants received monthly intravitreal injections of Faricimab (6 mg/0.05 mL) for three months (loading dose) in a sterile environment, following standard aseptic protocols. Patients observation and examination repeated after One month from the last injection to assess treatment response (BCVA, IOP and SD-OCT re-evaluation).The response to Faricimab was determined using both anatomical (CRT) and functional (BCVA) markers
干预措施: Faricimab Injection (Drug)
结局指标
主要结局
central retinal thickness
时间窗: one month after the last faricimab injection
optical coherence tomography angiography
次要结局
未报告次要终点
研究者
Duaa jabbar kadhim
principle investigator
Baghdad college of medicine