CTRI/2021/08/035406已完成Unknown
A prospective, open labelled, parallel, multicentric, comparative post marketing surveillance study to compare the efficacy and safety of AREDS 2 formula, the combination of Vitamin C, Vitamin E, Lutein, Zeaxanthin, Zinc and copper with the combination of Astaxanthin, L-Glutathione and Lutein (contains Zeaxanthin) in the patients of Age-related macular degeneration (AMD).
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 5
- 主要终点
- i. Visual acuity test.
研究概览
简要总结
This is a a post marketing surveillance study to compare the efficacy and safety for the investigational product 1 and 2. Investigational product 1 is AREDS 2 formula, each capsule contains combination of Vitamin C 250 mg, Zinc 40 mg, Lutein 5 mg, Zeaxanthin 1 mg, Copper 1 mg and Vitamin E 200 IU. Each tablet of Investigational Product 2contains combination of Astaxanthin 6 mg, L-Glutathione 5 mg and Lutein (contains Zeaxanthin 256 mcg) 3.2 mg. The clinical trial duration is of 365 days.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 50.00 Year(s) 至 85.00 Year(s)（—）
入选标准
- •Age: 50 years and above
- •Genders: both Males and Females
- •Patients eye (right or left or both) with confirmed diagnosis of nonexudative AMD with following drusen characteristics associated with high risk of progression to exudative AMD.
- •3.1 Soft type drusen 3.2 More than 5 drusen 3.3 Drusen size greater than 63 µm 3.4 Confluence of drusen (≥1) 3.5 Retinal pigment epithelium hyperpigmentation
- •Patients must be able to swallow capsules/tablet with the help of water
- •Best correction visual acuity better than 20/200 for each enrolled eye
- •Patients agreed to stop current use of supplements containing Vitamin C, Zinc, Lutein, Zeaxanthin, Copper, Vitamin E, Astaxanthin or Glutathione other than investigational product 1 or 2
- •Willing to sign on informed consent form
- •Patients who can adhere to the study protocol for the study duration.
排除标准
- •Patients with exudative AMD in the recruited eye.
- •Any retinal pathology other than AMD.
- •Previous intravitreal injection, seizure disorder and cataract
- •Patient with ocular or systemic medication known to be toxic to the lens, retina or optic nerve.
- •Patient with history of diabetic retinopathy or presence of vitreous haemorrhage or retinal detachment or macular hole.
- •A chronic requirement for any systemic or ocular medication administered for other disease and known to be toxic to retina or optic nerve.
- •IOP ≥26 mmHg (Participant might have glaucoma)
- •Cataract surgery within 3 months.
- •Previous daily supplementation with 2 mg or more Lutein for period of 1 year or more prior to date of randomization.
- •Patients with Hemochromatosis.
- •Patients with Wilson’s disease recent diagnosis of oxalate kidney stones.
- •Patients known to be hypersensitive to any of the excipient of the investigational products.
- •Patients who cannot adhere to the Protocol (Mentally Ill and Patients with Psychological problem)
- •Any disease with a poor 1 year survival prognosis.
- •Pregnant or lactating woman.
结局指标
主要结局
i. Visual acuity test.
时间窗: Day 0, 180 and 365
次要结局
- i. Vision Impairment Questionnaire(ii. Vision related quality of life)
研究者
研究点 (5)
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