NEWTON: A Single-center Open Label Study Evaluating Intravitreal Aflibercept Injection (IAI) for Previously Treated Macular Edema Associated With Central Retinal Vein Occlusions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Duration of Intravitreal Aflibercept on Treatment Interval
研究概览
简要总结
The purpose of the study is to determine the effect of Intravitreal Aflibercept Injection (IAI) on previously treated Central Retinal Vein Occlusions (CRVOs) with other Anti-VEGF agents.
详细描述
This prospective, open-label, single-center, nonrandomized, investigator-sponsored clinical study seeks to investigate the visual outcomes of a treat and extend dosing regimen of intravitreal aflibercept injection for macular edema following CRVO. All patients will receive IAI 2 mg at baseline and Week 4. If the pre-defined extension criteria are met at the 4-week visit, and at any follow up visit, the patient will receive a mandated treatment, and the next visit will be extended by two weeks. If the extension criteria are not met on a follow-up visit, the treatment interval will be continued to be reduced by 1 week. If criteria are still not met despite treatment at the reduced interval, treatment will be administered as usual and follow up interval will continue to be reduced by 1 week until the criteria are met or a 4-week interval is reached. Treatment of IAI is rendered at every visit.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 and above with documented history of center-involved macular edema secondary to CRVO.
- •Patients must have received treatment for at least 6 months before baseline, with 3 initial loading doses, and evidence of recurrence of edema when extended beyond 4 weeks.
- •Protocol refracted ETDRS BCVA of 20/25 to 20/320 (73-24 letters).
- •Willing and able to comply with clinic visits and study-related procedures.
- •Provide signed informed consent.
排除标准
- •Prior panretinal or macular laser photocoagulation
- •Previous use of intraocular corticosteroids or use of periocular corticosteroids within the 3 months prior to day 1
- •Prior treatment with systemic anti-VEGF agents
- •Presence of iris neovascularization
- •Vitreous hemorrhage in the Study Eye
- •Traction retinal detachment, or preretinal fibrosis involving the macula
- •Diabetic macular edema or diabetic retinopathy, defined as eyes of diabetic patients with more than 1 microaneurysm outside the area of the vein occlusion.
- •Infectious blepharitis, keratitis, scleritis, or conjunctivitis.
- •Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure equal or greater than 30mmHg despite treatment with anti-glaucoma medication)
- •Concurrent eye disease in the study eye that could compromise visual acuity (e.g. advanced glaucoma, age-related macular degeneration, etc)
- •Any concurrent intraocular condition in the study eye (e.g. glaucoma) that, in the opinion of the investigator, could either require medical or surgical intervention during the 52 weeks study period to prevent or treat visual loss that might result from that condition.
- •Pregnant or breast-feeding women
- •Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (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 [IUD]; bilateral tubal ligation; vasectomy; condom plus, contraceptive sponge, foam or jelly, or diaphragm) *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 child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
研究组 & 干预措施
Aflibercept (2.0 mg)
Intravitreal Aflibercept (2.0 mg)
干预措施: Aflibercept (2.0 mg) (Drug)
结局指标
主要结局
Duration of Intravitreal Aflibercept on Treatment Interval
时间窗: 52 Weeks
Mean number of weeks between each injection where there is no macular edema
次要结局
- Change in Visual Acuity(52 Weeks)
- Retinal Thickness(52 Weeks)
- Adverse Events(52 Weeks)
- Number of Treatments(52 Weeks)
研究者
Rahul Khurana, M.D.
Principal Investigator
Northern California Retina Vitreous Associates