Phase 4 Study of Ranibizumab for the Treatment of Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Initial Fair Visual Acuity
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity
研究概览
简要总结
The purpose of this study is to determine the effect of ranibizumab for the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial fair visual acuity.
详细描述
Lucentis was approved for ME due to BRVO based on the results from BRAVO study. The inclusion criteria in BRAVO was "best corrected visual acuity (BCVA) 20/40 to 20/320". Therefore, the patients with VA better than 20/40 who are out of inclusion criteria of BRAVO study had no treatment and just wait to reach spontaneous improvement. But, there is unmet needs of these patients and, in actual clinical practice, many retina specialists treat these patients with Ranibizumab. These patients have been experiencing VA improvement after the injection. Based on these clinical backgrounds, the investigator wants to suggest the treatment guidelines in these patients group, which is, early treatment of ranibizumab would be effective and increase patients' QOL. In other words, there are many experiences in these cases among ophthalmologists, but there have been no clinical trials that can endorse the treatments. To confirm the efficacy of ranibizumab in patients with initial fair vision, the investigators started the prospective randomized clinical trial on the efficacy and safety of ranibizumab for the patients.
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
- Single (Participant)
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
- •Foveal center-involving macular edema secondary to BRVO diagnosed within 12 months before study enrollment
- •ETDRS chart BCVA: 63 to 77 letters (20/32 to 20/50 Snellen equivalent)
- •CFT >= 300 um (mean of measurements obtained at screening and Day 0)
- •Signed consent informed
- •male or female, age ≥18 years old
排除标准
- •Prior episode of RVO: Past history of RVO in the study eye diagnosed before 1 year of study enrollment.
- •BCVA improvement >10 letters between screening and Day 0
- •History of other ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration)
- •Laser treatment within 3 months before baseline
- •Intraocular corticosteroid use within 3 months before baseline
- •Anti-vascular endothelial growth factor (VEGF) treatment in the study or fellow eye within 3 months before baseline
- •Intraocular surgery other than cataract surgery, Cataract surgery within 6 months before baseline
- •Stroke or myocardial infarction ≤3 months before baseline
- •Pregnancy or plan to have baby in female
研究组 & 干预措施
Ranibizumab group
Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.
干预措施: Ranibizumab (Drug)
Ranibizumab group
Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.
干预措施: Rescue laser (Procedure)
Standard of care group
Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.
干预措施: Sham injection (Device)
Standard of care group
Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.
干预措施: Rescue laser (Procedure)
结局指标
主要结局
Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity
时间窗: 1 year
次要结局
- Mean change from baseline ETDRS letter score over time(6 months and 1 year)
- Percentage of patients losing < 10 letters in ETDRS letter score from baseline BCVA(6 months and 1 year)
- Percentage of patients with central foveal thickness (CFT) of < 300 um(6 months and 1 year)
- Percentage of patients gaining 10 or more letters in ETDRS letter score from baseline BCVA(6 months and 1 year)
- Percentage of patients gaining < 10 letters in ETDRS letter score from baseline BCVA(6 months and 1 year)
- Safety outcomes(6 months and 1 year)
- Proportion of patients with who at least maintain baseline BCVA(6 months and 1 year)
- Mean change from baseline CFT over time(6 months and 1 year)
- Mean change from baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) distance activities subscale score(6 months and 1 year)
- Mean change from baseline in contrast sensitivity(6 months and 1 year)
- Mean change from baseline in multifocal electroretinogram (mfERG) P1 amplitude(6 months and 1 year)
- Percentage of patients losing 10 or more letters in ETDRS letter score from baseline BCVA(6 months and 1 year)
研究者
Kyu Hyung Park
Associate Professor
Seoul National University Bundang Hospital