Everads Injector in suprachoroidal administration of an approved TA suspension for the treatment of patients with Diabetic Macular Edema: An open label safety and performance pilot study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- •Frequency of treatment-emergent adverse events & serious adverse events (6 weeks).
研究概览
简要总结
Approximately 10 Male or female subjects aged more than or equal to 18 years diagnosed with type 1 or type 2 diabetes mellitus will be taken. It is an open label study, there is no randomization and assignment to cohort is sequential. The investigational product is Everads Injector (for target rapid delivery of therapy via suprachoroidal route. The study includes two cohorts of subjects. The first cohort will include 5 subjects with BCVA worse than 6/30 that will be injected with 100ul (4mg of TA) and the second cohort will include 5 subjects with BCVA worse than 6/30 that will be injected with 150ul (6mg of TA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females more than or equal to 18 years of age with a diagnosis of type 1 or type 2 diabetes mellitus.
- •DME with central involvement at the screening visit, of more than or equal to 320 for males or more than or equal to 305 for females on Spectralis (Heidelberg), or more than or equal to 305 for males or more than or equal to 290 for females with Cirrus (Zeiss) by spectral domain optical coherence tomography (SD-OCT).
- •ETDRS BCVA letter score of less than 6/30 in the study eye for both the cohorts, with second eye BCVA of 6/21 or better in both the cohorts.
- •4.If both the eyes are eligible, the worse eye should be included in the trial and the other eye should receive standard care.
- •If both eyes are eligible and have identical VA, the right eye needs to be included in the study.
- •The untreated eye should receive the standard care by the PI post study treatment and follow up duration.
- •5.Have shown no response to three previous IVT treatment with antivascular endothelial growth factor (VEGF) agents.
- •6.Understands the language of the informed consent; willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits.
- •7.For women at childbearing age: agreement to remain abstinent or use acceptable contraceptive methods.
排除标准
- •1.Evidence of macular edema due to any cause other than Diabetic retinopathy in the study eye.
- •2.Prior treatment with pan retinal photocoagulation or focal laser photocoagulation in the study eye within 90 days of screening visit.
- •3.Intraocular pressure more than or equal to 21 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye.
- •4.History of any prior ophthalmic surgeries in the study eye within 90 days of the screening visit.
- •5.Patients for whom enrollment into the study, in the principal investigator’s opinion, would put the eye at undue risk for vision loss.
- •6.Previous treatment for DME with any intravitreal injection in the study eye in the last 90 days prior to the screening visit.
- •7.Any previous treatment with Ozurdex® implant in past 6 months.
- •8.Any previous treatment with Iluvien®.
- •9.Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or the Screening visit.
- •10.Any other pre-existing eye conditions or surgical complications that would interfere with the interpretation of study endpoints.
- •11.Current iris neovascularization, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involving the macula in the study eye.
- •12.Known hypersensitivity to any component of or to used suspension or topical anesthetic.
- •13.Known allergy to nickel.
- •14.Uncontrolled blood pressure.
- •15.Pregnant or lactating women.
结局指标
主要结局
•Frequency of treatment-emergent adverse events & serious adverse events (6 weeks).
时间窗: Day 1 to Day 42
Treatment-emergent adverse events are defined as an event that emerges following administration of TA with Everads Injector at Visit 2.
时间窗: Day 1 to Day 42
•Frequency of adverse device effects & frequency of serious adverse device effects throughout the study period (6 weeks) Adverse device effects and serious adverse device effects are defined as effects that emerge following the administration of the Everads Injector on Visit 2.
时间窗: Day 1 to Day 42
次要结局
- •Confirmation of delivery into the suprachoroidal space by EDI-OCT.(Day 1)