NCT05699759已完成1 期
A Non-randomized, Open Label, Safety and Efficacy Study Evaluating a Single Dose of Kamuvudine-8 (K8) for the Treatment of Patients with Diabetic Macular Edema
Michelle Abou-Jaoude1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年1月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Mean change in central subfield thickness
研究概览
简要总结
This study is designed to assess the safety and initial evidence of efficacy of the novel compound SOM-401 (K8), a derivative of a nucleoside reverse transcriptase inhibitor, in subjects with untreated, clinically significant, diabetic macular edema (DME).
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
- •18 years or older
- •BCVA of ≥ 24 and ≤ 73 letters (20/40 or worse but at least 20/320) by an ETDRS chart. BCVA of the non-study eye must be no worse than 20/400)
- •Diagnosis of diabetes mellitus, type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy.
- •DME based on investigator's clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and spectral domain-optical coherence tomography (SD-OCT)
- •Mean foveal thickness of at least 300 µm by SD-OCT
- •Ability and willingness to comply with the treatment and follow-up procedures
- •Ability to understand and sign the informed consent form
- •Intraocular pressure of ≤ 21 on 2 or less IOP lowering medications
排除标准
- •Pregnant patients, currently lactating patients, or females of childbearing potential (unless using reliable contraception such as double barrier, surgical sterilization, oral contraceptives, intrauterine device (IUD), etc.)
- •Allergy or hypersensitivity (known or suspected) to fluorescein or any component of the investigational product or delivery system
- •Any ocular surgery in the study eye within 12 weeks of screening
- •Any history of vitrectomy in the study eye
- •Aphakia in the study eye
- •Presence of severe foveal ischemia, defined as foveal avascular zone (FAZ) of >1.5 mm2 on OCT-Angiography
- •Prior intraocular or periocular treatment for DME
- •Macular laser for the treatment of diabetic macular edema within 12 weeks of screening
- •Any change in systemic steroidal therapy within 3 months of screening
- •Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
- •History or presence of viral disease of the cornea or conjunctiva
- •History or presence of any disease or condition that in the investigator's opinion would preclude study treatment or follow-up or that in the opinion of the investigator would render them as unlikely to benefit from study treatment.
- •Any lens or corneal opacity which impairs visualization of the posterior pole
- •Participation in another clinical trial within 12 weeks before the screening visit or during the study
- •Expectation that subject will be moving away from the area of the clinical treatment center without the ability to return for visits within the study period
研究组 & 干预措施
Patients with Diabetic Macular Edema
Experimental
Patients with Diabetic Macular Edema
干预措施: K8 (Drug)
结局指标
主要结局
Mean change in central subfield thickness
时间窗: At week 4 (change as measured from baseline)
Central subfield thickness (CST) measured on spectral domain-optical coherence tomography (SD-OCT)
Mean change in best-corrected visual acuity (BCVA)
时间窗: At week 4 (change as measured from baseline)
best-corrected visual acuity as defined by the number of letters read on the scale set by the ETDRS (Early Treatment of Diabetic Retinopathy Study). (More letters read equates to better visual acuity)
Adverse Events
时间窗: Within the study period (of 24 weeks)
Frequency of participants experiencing ocular or systemic adverse events.
次要结局
- Change in score on the ETDRS Multi-Step Scale of Diabetic Retinopathy(24 weeks)
- Visual acuity(24 weeks (at 2, 4, 8, 12, 16, and 24 weeks))
- Resolution of macular edema(24 weeks (at 2, 4, 8, 12, 16, and 24 weeks))
- Clinically significant change in visual acuity(24 weeks (at 2, 4, 8, 12, 16, and 24 weeks))
- Change in retinal thickening(24 weeks (at 2, 4, 8, 12, 16, and 24 weeks))
- Change in hard exudates(24 weeks (at 2, 4, 8, 12, 16, and 24 weeks))
- Change in foveal avascular zone.(24 weeks (at 2, 4, 8, 12, 16, and 24 weeks))
- Proportion of subjects requiring rescue treatment(24 weeks (at 2, 4, 8, 12, 16, and 24 weeks))
- Proportion of subjects requiring vitrectomy(24 weeks (at 2, 4, 8, 12, 16, and 24 weeks))
- Mean change in central subfield thickness at other study timepoints(24 weeks (at 2, 8, 12, 16, and 24 weeks))
- Mean change in best-corrected visual acuity (BCVA) at other study timepoints(24 weeks (at 2, 4, 8, 12, 16, and 24 weeks))
研究者
Michelle Abou-Jaoude
Assistant Professor
University of Kentucky
研究点 (1)
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