A Randomized, Controlled Interventional Phase 2b (Proof of Concept) Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Ranibizumab Guided by Morphological Changes Documented by Optical Coherence Tomography (OCT) in Subjects With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- change of best corrected visual acuity (BCVA) measured in ETDRS letters
研究概览
简要总结
The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is guided by morphological macular changes detected by OCT compared to re-treatment according to SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease of BCVA).
详细描述
In a prospective, randomized, interventional, controlled phase IIb clinical the functional results of treatment with ranibizumab in patients with macular edema due to branch retinal vein occlusion when given according to morphological changes detected by OCT compared to standard re-treatment criteria according to SmPC
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 (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
- •Recurrence of macular edema defined as any kind of fluid accumulation in the macula (microcystic changes with or without increase of central retinal thickness) detected by OCT in the month 1 to 6 after the last Lucentis injection without any decrease of BCVA measured with ETDRS charts
- •Diagnosis of BRVO with macular edema treated with at least three intravitreally applied injections of ranibizumab after the up-load phase of treatment
- •Age ≥ 18 years
- •Ability and willingness to attend all scheduled visits and assessments
- •For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
排除标准
- •Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
- •Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
- •Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) prior to study entry
- •History of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months
- •Pregnancy (positive pregnancy test) or lactation
- •History of allergy to humanized antibodies or any component of the ranibizumab formulation
研究组 & 干预措施
OCT guided group
Patients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab if the morphological macular changes for recurrence of macular edema (microcystic changes with or without increase of central retinal thickness) will be detected by OCT.
干预措施: Ranibizumab (Drug)
Standard treatment
Patients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab according to the in SmPC defined re-treatment criteria (re-injection if decrease of BCVA will be detected).
干预措施: Ranibizumab (Drug)
结局指标
主要结局
change of best corrected visual acuity (BCVA) measured in ETDRS letters
时间窗: 12 months
次要结局
- Central retinal thickness (CRT)(12 months)
- Number of applied ranibizumab injections(12 months)
- • Rates of patients developing a neovascularisation of the retina/ anterior segment(12 months)
- Assessment of safety: serious adverse events/ reactions; AEs/ARs(12 months)
研究者
PD Dr. habil. Matus Rehak
MD, Ph.D
University of Leipzig