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.

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).

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/08/035406

Enrollment

350

Registered

2021-08-04

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H353- Degeneration of macula and posterior pole

Interventions

Intervention1: Investigational product 1: 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. Intervention2: Investigatio

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 Âµm 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

Exclusion criteria: 1. Patients with exudative AMD in the recruited eye. 2. Any retinal pathology other than AMD. 3. 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. 5. Patient with history of diabetic retinopathy or presence of vitreous haemorrhage or retinal detachment or macular hole. 6. A chronic requirement for any systemic or ocular medication administered for other disease and known to be toxic to retina or optic nerve. 7. IOP >=26 mmHg (Participant might have glaucoma) 8. Cataract surgery within 3 months. 9. Previous daily supplementation with 2 mg or more Lutein for period of 1 year or more prior to date of randomization. 10. Patients with Hemochromatosis. 11. Patients with Wilsonâ??s disease recent diagnosis of oxalate kidney stones. 12. Patients known to be hypersensitive to any of the excipient of the investigational products. 13. Patients who cannot adhere to the Protocol (Mentally Ill and Patients with Psychological problem) 14. Any disease with a poor 1 year survival prognosis. 15. Pregnant or lactating woman.

Design outcomes

Primary

Measure	Time frame
i. Visual acuity test. Timepoint: Day 0, 180 and 365	—

Secondary

Measure	Time frame
i. Vision Impairment Questionnaire ii. Vision related quality of lifeTimepoint: Day 0, 180 and 365	—

Countries

India

Contacts

Public ContactLalit Jeevan Pawaskar

Centaur Pharmaceuticals Pvt Ltd

lalit@centaurlab.com8793725153

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026