Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results
试验速览
- 阶段
- 4 期
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Resolution time of intraretinal cysts and sub retinal fluid on OCT
研究概览
简要总结
This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD).
详细描述
Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be followed for 48 weeks. All subjects will receive 2.0 mg intravitreal aflibercept injections with three initial monthly doses, and mandatory doses at Weeks 16, 24, 32, and 40. Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on Optical Coherence Tomography (OCT) and/or a decrease in visual acuity of greater than or equal to 5 letters from the best previous visit. Only one eye will be enrolled in the study.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Age 50 years and above.
- •Choroidal neovascularization secondary to AMD with central retinal thickness greater than or equal to 300um.
- •Best corrected visual acuity in the study eye between 20/40 and 20/400 using an ETDRS chart -
排除标准
- •Pregnancy (positive urine 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.
- •Participation in a study or an investigational drug or device within the past 30 days prior to enrolling in the study.
- •Presence of significant subfoveal fibrosis or atrophy.
- •Previously treated subjects:
- •Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline More than six (6) prior treatments with anti-VEGF therapy in the study eye within 1 year.
- •Prior treatment with PDT within the past 3 months or more than 2 prior PDT treatments.
- •Prior treatment with intravitreal aflibercept injection Prior treatment with triamcinolone in the study eye within 6 months of baseline.
- •Prior treatment with dexamethasone in the study eye within 30 days prior to baseline.
- •Intraocular surgery (including cataract surgery)in the study eye within 2 months preceding baseline
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
- •Active intraocular inflammation (grade trace or above) in the study eye
- •Current vitreous hemorrhage in the study eye
- •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- •Uncontrolled glaucoma in the study eye (defined as IOP greater than or equal to 30 mmHg despite treatment with anti-glaucoma medication)
- •History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- •History of allergy to fluorescein, ICG or iodine, not amenable to treatment
- •History of retinal pigment epithelial tear or rip.
研究组 & 干预措施
Intravitreal Aflibercept injection
Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mg) via intravitreal injection once every 8 weeks (2 months).
干预措施: Intravitreal Aflibercept injection (Drug)
结局指标
主要结局
Resolution time of intraretinal cysts and sub retinal fluid on OCT
时间窗: 12 months
次要结局
- The percentage of subjects who lose less than 15 letters of visual acuity(12 months)
- Mean change in visual acuity(12 months)
- Mean change in OCT central foveal thickness(12 months)
- The percentage of subjects with no fluid on OCT(12 months)
- The percentage of subjects who gain greater than or equal to 15 letters of visual acuity(12 months)
- Mean change in macular volume(12 months)
- Mean number of injections of 2.0 mg intravitreal aflibercept injection(12 months)
- Quantitative change in area (microns) from baseline in choroidal neovascular lesion characteristics/size as measured by ICG/FA/Fundus photos(12 months)
研究者
Rhonda Weeks
Gaurav K. Shah, MD, Principal Investigator
Retina Research Institute, LLC