Chilean Interventional Open Label Pilot Study, to Assess the Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Best Correct Visual Acuity (BCVA)
研究概览
简要总结
Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic macular edema (DME), retinal vein occlusion and age-related macular degeneration.
Currently, there is limited epidemiologic information in Chile regarding the incidence of DME and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and functional improvement following this treatment and to increase the local experience regarding the use of anti-VEGF in the treatment of diabetic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of macular edema due to diabetes (confirmed by fundus photography, and/or fluorescein angiography, and/or OCT) in at least one eye.
- •Vision impairment due to DME (BCVA ETDRS letter score at 4 meters between 20 and 70 letters (6/12 - 3/60 at Snellen chart).
排除标准
- •Laser photocoagulation in the study eye for the last 3 months.
- •Any history of any intraocular surgery in the study eye within the past 3 months.
- •Blood pressure >160/100 mmHg.
- •Proliferative Diabetic Retinopathy.
- •Any other protocol inclusion/exclusion criteria that may apply.
研究组 & 干预措施
Ranibizumab
Ranibizumab treatment
干预措施: Ranibizumab Intravitreal injections (Drug)
结局指标
主要结局
Mean Change From Baseline in Best Correct Visual Acuity (BCVA)
时间窗: baseline, week 48
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.
次要结局
- Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36(Baseline, Week 4, 8, 12, 24 and 36)
- Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT)(Baseline, week 48)
- Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period.(Week 48)
- Number of Participants With Letters Gain / Loss at Week 52(Baseline, Week 52)
- Change in Mean Visual Function Questionnaire (VFQ-25)(Baseline, week 48)