Intravitreal Aflibercept Injection (IAI) for Radiation Retinopathy Trial (ARRT)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Safety of intravitreal Aflibercept for the treatment of radiation retinopathy - Assessed by incidence of adverse events.
研究概览
简要总结
The ARRT trial will assess the safety and efficacy of 2mg aflibercept for the treatment of radiation retinopathy, including maculopathy and optic neuropathy over 52 weeks.
详细描述
Approximately 40 eyes will be randomized (1:1 ratio) into either Group 1 or Group 2. Slit lamp exam and Indirect ophthalmoscopy will be performed at every study visit, where retinopathy level will be assessed. SD-OCT will be performed at each visit. Fluorescein angiogram will be performed at screen, week 26 and week 52. All other imaging studies will be standard of care at the discretion of the investigator.
This trial will compare the results of 2 groups, with different treatment intervals, to assess the safety of intravitreal Aflibercept injections (IAI) for the treatment of radiation retinopathy. Patients in each group will be followed for a total of 52 weeks.
Group 1: 15 Patients will receive a loading dose of 3 IAI. They will receive 2 mg IAI at screening/baseline, week 4, week 8, and week 12. A follow-up visit will occur at week 12. If the extension criteria are met, the patient will be extended by 2 weeks. The patient will continue to be followed per the treat and extend protocol described below.
Group 2: Patients will not receive a loading dose. They will receive 2 mg IAI at screening/baseline followed by a visit at week 4. At week 4, if the extension criteria are met, the patient will be extended by 2 weeks. The patient will continue to be followed per the treat and extend protocol described below.
Treat & Extend Protocol Patients can be extended as long as they meet the following criteria -
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
- 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
- •Age > 18 years of age
- •Clinically identifiable radiation retinopathy with evidence of fluid on SD-OCT causing vision loss in the study eye
- •Undergone either ocular or orbital radiation for any primary ocular or orbital cancer within clinical evidence of having radiation retinopathy
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •A patient who meets any of the following criteria will be excluded from the study:
- •Metastatic cancer or any active primary cancer, at time of enrollment
- •Prior treatment with anti VEGF in the study within 60 days of screen in the study eye
- •Prior intravitreal or subconjunctival treatment with cortical steroids within 90 days of screen in the study eye
- •Macular ischemia (defined as greater than 5 disc areas), as assessed by the investigator
- •Media opacity obscuring a view of the fundus or any other reason for vision loss other than radiation retinopathy.
- •Evidence of infectious ocular infection, in the study eye, at time of screening
- •Pregnant or breast-feeding women
- •Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception start of the first treatment, during the study, and for at least 3 months after the last dose. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.
- •Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
研究组 & 干预措施
Loading Dose
20 Patients will receive 4, 2 mg IVT Aflibercept (IAI) a month apart, screening/baseline, weeks 4, 8, & 12. At week 12, patient will be followed & treated per treat & extend protocol.
Treat & Extend Protocol entails patients being extended as long as:
- Absence of retinal fluid (resolution of intraretinal & subretinal fluid on SD-OCT; Small intraretinal cysts that don't distort foveal contour on SD-OCT are acceptable & can be considered "dry".) AND
- < 5 ETDRS letter loss from previous visit, due to new or persistent retinal edema.
Each extension will be 2 weeks in duration beyond the initial 4-week interval. If the extension criteria are not met on a follow-up visit, treatment interval will be reduced by 2 weeks. Follow up interval will continue to be reduced by 2 weeks until the extension criteria are met or a 4-week interval is reached.
干预措施: Aflibercept (Drug)
Treat and Extend
20 Patients will receive 2 mg IVT Aflibercept (IAI) at screening/baseline followed by a visit at week 4. At week 4, patient will be treated & followed per the treat & extend protocol.
Treat & Extend Protocol entails patients being extended as long as:
- Absence of retinal fluid (resolution of intraretinal & subretinal fluid on SD-OCT; Small intraretinal cysts that don't distort foveal contour on SD-OCT are acceptable & can be considered "dry".) AND
- < 5 ETDRS letter loss from previous visit, due to new or persistent retinal edema.
Each extension will be 2 weeks in duration beyond the initial 4-week interval. If the extension criteria are not met on a follow-up visit, treatment interval will be reduced by 2 weeks. Follow up interval will continue to be reduced by 2 weeks until the extension criteria are met or a 4-week interval is reached.
干预措施: Aflibercept (Drug)
结局指标
主要结局
Safety of intravitreal Aflibercept for the treatment of radiation retinopathy - Assessed by incidence of adverse events.
时间窗: 52 Weeks
The primary objective of the study is to assess the safety of 2 mg intravitreal Aflibercept injections (IAI) for the treatment of radiation retinopathy including maculopathy and optic neuropathy. Assessed by incidence of adverse events.
次要结局
- Resolution of macular edema (% dry)(52 Weeks)
- Resolution of retinal hemorrhage, retinal exudates, optic disc edema, and capillary non-perfusion(52 Weeks)
- Dosing frequency of intravitreal aflibercept injections(52 Weeks)
- Incidence of neovascularization, vitreous hemorrhage, and need for vitrectomy(52 Weeks)
- Resolution of macular edema (CRT)(52 Weeks)
- Stabilization and improvement in visual acuity(52 Weeks)
研究者
Amy C Schefler, MD
Principal Investigator
Greater Houston Retina Research