Subconjunctival Aflibercept Injection for Pseudophakic Cystoid Macular Edema
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This research study is being conducted to determine the safety and tolerability of subconjunctival injections of aflibercept in the treatment of pseudophakic cystoid macular edema that has not responded well to first-line standard of care treatment (eye drops).
Pseudophakic cystoid macular edema (CME) is swelling of the retina that can occur weeks or years after cataract surgery and typically results in decreased vision. Subconjunctival injections are injections placed just beneath the clear membrane (conjunctiva) of the eye.
A recent report of one patient who received two subconjunctival injections of a similar medication to the one being studied here indicated that subconjunctival injections of this class of medication may be an effective and less invasive alternative to intravitreal injections for pseudophakic CME. Because of the similarity of the drugs and the patient's treatment success, we would like to see if subconjunctival injection(s) of aflibercept will work in treating pseudophakic CME. If successful, the risk of an intraocular infection and glaucoma that comes with standard of care treatments might be greatly reduced.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with pseudophakic CME defined as central retinal thickness (CRT)>300 microns, presence of intraretinal cysts on optical coherence tomography (OCT) and visual acuity <=20/32 with petaloid leakage on fluorescein angiogram and late leakage at the disc
- •Diagnosed with "recalcitrant" CME, defined as less than a 15% decrease in CRT after at least 6 weeks of topical non-steroidal anti-inflammatory drug
- •Has had cataract surgery in the study eye with posterior chamber or anterior chamber intraocular lens implantation
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •Retinal diseases (including diabetic retinopathy, retinal vein or artery occlusion, neovascular age-related macular degeneration, radiation retinopathy, vitreomacular traction, epiretinal membrane).
- •Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
- •Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
- •Prior treatment with sub-Tenon's or intravitreal steroids.
- •Prior treatment with an intravitreal anti-vascular endothelial growth factor (VEGF) agent in the study eye or systemic administration of anti-VEGF.
- •Use of topical prostaglandin analogues or pilocarpine.
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with glaucoma medications.
- •Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye.
- •Vision loss in the study eye, determined by the investigator to be from a cause other than CME, e.g. optic neuropathy, end-stage glaucoma.
- •Any significant media opacity including vitreous hemorrhage or corneal scarring.
- •Fluorescein dye allergy or intolerance
- •Allergy to aflibercept or any of the components
- •Cerebrovascular accident or myocardial infarction within 1 year of the screening visit.
- •Pregnant or breast-feeding women
- •Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception starting at least 2 menstrual cycles prior to the baseline visit, during the study and in the 3 months immediately following the last dose of study drug.
研究组 & 干预措施
Subconjunctival aflibercept
Subconjunctival aflibercept 2 milligrams (mg) /0.05 milliliters (mL) administered at baseline visit and possibly again at Month 1 visit depending on initial response.
干预措施: Aflibercept (Drug)
结局指标
主要结局
Adverse Events
时间窗: Month 2
Systemic and ocular adverse events of subconjunctivally administered aflibercept injection in the treatment of pseudophakic cystoid macular edema at Month 2
次要结局
- Change in visual acuity(Month 2 and Month 6)
- Change in central retinal thickness(Month 2 and Month 6)
- Proportion of patients needing re-treatment(Month 1)
- Proportion of patients needing additional non-study treatment though Month 6(Month 6)
- Adverse Events - end of study period(Month 6)