Evaluating the Efficacy and Safety of Brolucizumab Versus Aflibercept on Visual and Anatomical Outcomes in Diabetic Macular Edema: A Retrospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Best-Corrected Visual Acuity (BCVA) from Baseline to 6 Months
研究概览
简要总结
This retrospective, comparative cohort study included 38 eyes from 38 patients with center-involving diabetic macular edema (DME), treated at Benha University Hospital. Patients were divided into two groups: 19 eyes received intravitreal Brolucizumab (6 mg), and 19 eyes received intravitreal Aflibercept (2 mg), with the aim of comparing their efficacy and safety over a 6-month period.
详细描述
The study retrospectively evaluated real-world outcomes of anti-VEGF therapy in treatment-naïve patients with center-involving DME. Participants were assigned into two equal groups based on the anti-VEGF agent received: Group A was treated with intravitreal Brolucizumab (6 mg), and Group B with intravitreal Aflibercept (2 mg). All patients underwent comprehensive ophthalmic evaluation at baseline and at monthly intervals, including best-corrected visual acuity (BCVA) assessment and optical coherence tomography (OCT) to monitor central retinal thickness (CRT). The primary outcomes were changes in BCVA and CRT from baseline to 6 months, while secondary outcomes included the number of injections received and any adverse events. This study aimed to provide comparative insights into the efficacy, anatomical response, and safety profile of the two anti-VEGF agents in managing DME in a real-world clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients diagnosed with center-involving diabetic macular edema (DME) confirmed by spectral-domain optical coherence tomography (SD-OCT).
- •Central macular thickness (CMT) > 350 µm at baseline.
- •Treatment-naïve patients (no prior intravitreal injections or laser therapy for DME).
排除标准
- •Patients with media opacity (e.g., corneal opacities, dense vitreous hemorrhage).
- •Significant cataract affecting visual acuity or OCT imaging quality.
- •Traction maculopathy or vitreomacular traction.
- •Central macular thickness < 350 µm at baseline.
- •History of vasculitis or autoimmune diseases (e.g., systemic lupus erythematosus [SLE]).
研究组 & 干预措施
Arm 1: Brolucizumab Group
Description:
This group included 19 eyes of 19 patients who received intravitreal Brolucizumab (6 mg/0.05 mL) injections for center-involving diabetic macular edema.
Intervention Type: Drug
Intervention Name: Brolucizumab 6 mg
Dose/Frequency: Administered intravitreally as needed based on clinical evaluation
干预措施: Intervention 1: Brolucizumab (Drug)
Arm 2: Aflibercept Group
This group included 19 eyes of 19 patients who received intravitreal Aflibercept (2 mg/0.05 mL) injections for center-involving diabetic macular edema.
Intervention Type: Drug
Intervention Name: Aflibercept 2 mg
Dose/Frequency: Administered intravitreally as needed based on clinical evaluation
干预措施: Intervention 2: Aflibercept (Drug)
结局指标
主要结局
Change in Best-Corrected Visual Acuity (BCVA) from Baseline to 6 Months
时间窗: Baseline and 6 months
Measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or Snellen equivalent, converted to logMAR. The primary measure is the mean change in BCVA after treatment with either Brolucizumab or Aflibercept.
Change in Central Retinal Thickness (CRT) from Baseline to 6 Months
时间窗: Baseline and 6 months
Assessed by spectral-domain optical coherence tomography (SD-OCT). The outcome is the mean change in CRT in micrometers, reflecting anatomical response to treatment.
次要结局
- Total Number of Intravitreal Injections Over 6 Months(From baseline to month 6)
研究者
Ehab Mohamed Elsayed Mohamed Saad
Lecturer
Benha University