A Double-Masked, Randomized, Active-Controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI]) in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 183
- 主要终点
- Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF
研究概览
简要总结
This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following inclusion criteria include, but are not limited to:
- •Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit
- •ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1
- •Provide signed informed consent
排除标准
- •The following exclusion criteria include, but are not limited to:
- •Current bilateral manifestation of BRVO
- •Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
- •Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves)
- •Uncontrolled diabetes mellitus (DM)
- •Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
- •Use of periocular corticosteroids in the study eye within 3 months before day 1
- •Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
- •Previous administration of systemic anti-angiogenic medications
- •Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye
研究组 & 干预措施
Macular Laser Photocoagulation Treatment (Control)
Participants will receive macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants will receive treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
干预措施: Macular Laser Photocoagulation (Procedure)
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Participants will receive 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group may receive laser rescue at week 36.
干预措施: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) (Drug)
结局指标
主要结局
Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF
时间窗: Baseline to week 24
Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.
次要结局
- Change From Baseline to Week 24 in BCVA Score - LOCF(Baseline to Week 24)
- Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF(Baseline to week 24)
- Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF(Baseline to week 24)