Anti-VEGF Therapy for Acute Thyroid Eye Disease (AcTED Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Primary Outcome: Safety
研究概览
简要总结
The primary objective of this clinical trial is to assess the safety and tolerability of sub-tenon aflibercept in combination with either saline or hyaluronidase (HA) in patients with acute Thyroid Eye Disease (TED) as assessed by the incidence and severity of adverse events from baseline to day 45.
Participants will undergo clinical examinations and receive three injections of aflibercept with saline, aflibercept with hyaluronidase, or hyaluronidase.
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
- Double (Participant, Care Provider)
盲法说明
Double-masked
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
- •Minimum of 18 years-old
- •Active Thyroid Eye Disease
- •Clinical Activity Score (CAS) between 3 and 5, inclusive
- •Phakic and pseudophakic eyes are allowed in the study.
- •Willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures
- •Willing and able to comply with clinic visits and study-related procedures
- •Only one eye will be enrolled. The worse eye (demonstrating any of these features:
- •worse HVF results, worse restricted motility, worse visual acuity, worse edema, worse proptosis, worse eyelid retraction) will be enrolled. If both eyes are equivalent, we will enroll the non-dominant eye.
排除标准
- •History of orbital, strabismus, or eyelid surgery or orbital radiation
- •Optic neuropathy or other vision-threatening signs
- •Patients currently on systemic or topical steroids. If they received steroids in the past, they would require a 6 week washout period and the cumulative dose of steroids must be less than 1 gram of methylprednisolone (or equivalent). During the washout period we will contact patients by phone weekly to monitor their safety and address any concerns they may have related to no longer taking steroids .
- •Patients who have taken teprotumumab (Tepezza.)
- •Patients who have received intraocular anti-VEGF medications within 1 year of screening
- •Patients who have a history of receiving systemic anti-VEGF
- •Presence of other retinal vascular diseases (diabetic retinopathy, vein occlusion) that could affect the VEGF levels within the eye
- •History of stroke or prior myocardial infarction
- •Known hypersensitivity to aflibercept
- •Infectious conjunctivitis, keratitis, or endophthalmitis of either eye
- •Presence of a glaucoma shunting or filtration device that is subconjunctival
- •Previous participation in any studies of investigational drugs within 1 month preceding Day 0
- •Any clinically significant acute or chronic medical condition that would preclude participation in a clinical study
- •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 plus contraceptive sponge, foam, or jelly)
- •History of hyaluronidase (HA) injection after the diagnosis of thyroid eye disease
- •Taking part in other research studies in the past 12 months that have involved radiation exposure
- •Participated in other research studies in the past 12 months that required radiologic imaging (particularly CT scans and not MRIs)
研究组 & 干预措施
Saline and aflibercept
Group 1: Sub-tenon's injection of saline followed by sub-tenon injection of aflibercept
干预措施: Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept (Drug)
Hyaluronidase and aflibercept
Group 2: Sub-tenon's injection of hyaluronidase (HA) followed by sub-tenon injection of aflibercept
干预措施: Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept (Drug)
Hyaluronidase alone
Group 3: Sub-tenon injection of HA injection alone
干预措施: Sub-tenon injection of hyaluronidase (HA) alone (Drug)
结局指标
主要结局
Primary Outcome: Safety
时间窗: 45 days
To assess the safety and tolerability of sub-tenon aflibercept in combination with either saline or hyaluronidase (HA) in patients with acute Thyroid Eye Disease (TED) as assessed by the incidence and severity of adverse events
次要结局
- Secondary Outcome: Change in Ocular Alignment(1-90 days)
- Secondary Outcome: Change in Vision measured by Ishihara color test(1-90 days)
- Secondary Outcome: Change in Pain/Discomfort Reported by Subjects(1-90 days)
- Secondary Outcome: Change in Proptosis by CT scan(1-90 days)
- Secondary Outcome: Change in Ocular Motility(1-90 days)
- Secondary Outcome: Change in Eyelid Retraction/Position(1-90 days)
- Secondary Outcome: Safety(Baseline to day 90)
- Secondary Outcome: Change in Proptosis measured by exophthalmometry(1-90 days)
- Secondary Outcome: Change in Vision measured by ETDRS BCVA(1-90 days)
- Secondary Outcome: Change in Visual Function(1-90 days)
- Secondary Outcome: Change in Clinical Activity(1-90 days)
- Secondary Outcome: Change in Ocular Muscle(1-90 days)
研究者
Nahyoung Grace Lee, MD
Physician
Massachusetts Eye and Ear Infirmary