Evaluation of the Possible Effects of Supplement Therapy With Oral Phenolics on Plasma CD-163 Biomarker in Patients With Different Subtypes of Age-related Macular Degeneration; a Double-blind Placebo Controlled Prospective Clinical Study
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Concentration of Plasma CD-163
研究概览
简要总结
In this multi-center study, possible effects of supplement treatment with oral phenolics on plasma CD-163 and progression of dry and wet age-related macular degeneration (AMD) via evaluating the CD163 before and after the prescription of this drug will be evaluated in patients with dry type AMD and Neo vascular age-related macular degeneration (nAMD).
Both AMD subgroups will be recruited. In terms of evaluation of the effects of phenolics (500 mg caplets/day) on AMD progression, patients will be randomized and divided into 2 subgroups i.e. (i) receiving phenolics supplementation; and, (ii) receiving placebo for 1 month. The phenolics/placebo caplets will resemble completely and be encoded at origin; Neither the participants nor the researchers will be informed about the codes until the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of intermediate to late AMD (dry AMD and nAMD )
- •Age-matched controls without any sign of AMD
- •Signed informed consent
排除标准
- •Systemic disease or other eye-related diseases (diabetes, immunologic or inflammatory, active or chronic infectious disease, active malignancy, uveitis, retinal vascular occlusive disease, glaucoma)
- •Systemic therapy with corticosteroids or biological drugs.
研究组 & 干预措施
placebo caplet intake
Prescription of oral phenolics 250 mg two times daily
干预措施: Placebo (Drug)
oral phenolics intake
Prescription of oral phenolics 250 mg two times daily
干预措施: Oral intake of medication (Drug)
结局指标
主要结局
Concentration of Plasma CD-163
时间窗: 1 month
Blood sampling
次要结局
- Decimal acuity of vision(1 month)
研究者
Zahra Rabbani Khah
Head of ophthalmic research center
Shahid Beheshti University of Medical Sciences