A comparative post marketing surveillance study to compare the efficacy and safety for 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.

Not Applicable

Completed

• Conditions: Degeneration of macula and posterior pole,

• Registration Number: CTRI/2021/08/035406
• Lead Sponsor: Centaur Pharmaceuticals Pvt Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-08
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 350

Inclusion Criteria

• Age: 50 years and above 2.
• Genders: both Males and Females 3.
• 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 4.
• Patients must be able to swallow capsules/tablet with the help of water 5.
• Best correction visual acuity better than 20/200 for each enrolled eye 6.
• 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 7.
• Willing to sign on informed consent form 8.
• Patients who can adhere to the study protocol for the study duration.

Exclusion Criteria

• Patients with exudative AMD in the recruited eye.
• Any retinal pathology other than AMD.
• Previous intravitreal injection, seizure disorder and cataract 4.
• 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) 8.
• 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) 14.
• Any disease with a poor 1 year survival prognosis.
• Pregnant or lactating woman.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
i. Visual acuity test.	Day 0, 180 and 365

Secondary Outcome Measures

Name	Time	Method
i. Vision Impairment Questionnaire	ii. Vision related quality of life

Trial Locations

Locations (5)

Allcure superspeciality hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Asian eye institute and laser centre pvt ltd; 🇮🇳 Mumbai, MAHARASHTRA, India

Dadar Eye and Gynaec Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Samarth eye care and laser centre; 🇮🇳 Mumbai, MAHARASHTRA, India

V Care Eye Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Allcure superspeciality hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Bapat Siddhesh Vishwanath

Principal investigator

9930925424

drsiddheshretina@gmail.com