REVOLUTIONARY: REtinal Vein OccLUsion Treatment With Scatter Laser Guided by Ultra Widefield angIOgraphy in combiNAtion With Ranibizumab Study Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
Branch retinal vein occlusion is a leading cause of vision loss. Treatment with ranibizumab (vascular endothelial growth factor (VEGF) inhibitor) on a monthly basis has been associated with improved vision results. There is a subgroup of patients with peripheral nonperfusion on ultrawidefield angiography that appears to be more dependent on anti-VEGF treatment.
In this trial the investigators compare the gold standard of monthly ranibizumab injections with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography. Each group will have monthly injections for the first six months, then as needed by either visual acuity decrease or increased retinal thickness for the subsequent six months.
The primary outcome is visual acuity. Secondary outcomes are reduction in optical coherence tomography, and number of ranibizumab injections
详细描述
SUBJECTS Subject Selection Twenty subjects from a single site in the United States will be enrolled. Eligible subjects will have provided informed consent. (See Appendix A, the study flow chart, for screening assessments.)
Inclusion Criteria
Subjects will be eligible if the following criteria are met:
Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 18 years
Disease related considerations:
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be eligible if the following criteria are met:
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 18 years
- •Disease related considerations:
- •Study eye with macular edema secondary to branch retinal vein occlusion characterized by:
- •Fovea-involved macular edema of less than 12 months peripheral nonperfusion defined as at least 5 disc areas of contiguous nonperfusion on ultra-widefield fluorescein angiography absence of macular traction on clinical exam, UWFA, and OCT.
- •Study eye with best corrected visual acuity between 20/40 (≤ 73 letters on ETDRS chart) and 20/320 (≥ 19 letters on ETDRS chart)
- •Other considerations
- •Patient able to complete all study visits
排除标准
- •Subjects who meet any of the following criteria will be excluded from this study:
- •Pregnancy (positive pregnancy test) or lactation. Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- •Prior enrollment in the study
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another simultaneous medical investigation or trial
- •Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months
- •Previous macular or panretinal scatter laser photocoagulation
- •Previous pars plana vitrectomy
- •Visually-significant significant cataracts as primary reason for vision loss
- •Myocardial infarction or cerebrovascular accident within 6 months
研究组 & 干预措施
Peripheral Laser + Ranibizumab
Angiography-directed peripheral laser + ranibizumab
干预措施: Ranibizumab (Drug)
Peripheral Laser + Ranibizumab
Angiography-directed peripheral laser + ranibizumab
干预措施: Peripheral Laser (Procedure)
Ranibizumab
Ranibizumab
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Visual Acuity
时间窗: 6 and 12 months
ETDRS visual acuity
次要结局
- Number of Ranibizumab Injections(12 months)
- Retinal Thickness(6 and 12 months)
研究者
Ivan J. Suner, MD
Director of Clinical Research
Retina Associates of Florida, P.A.