A prospective, controlled, monocentric study comparing local complement activation in the aqueous humour of the eye in patients with and without oral supplemental zinc substitution as part of the dietary therapy of age-related macular degeneration (AMD)

A prospective, controlled, monocentric study comparing local complement activation in the aqueous humour of the eye in patients with and without oral supplemental zinc substitution as part of the dietary therapy of age-related macular degeneration (AMD) - LOCA-AMD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012507

Enrollment

Registered

2017-06-01

Start date

2017-08-29

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

H35.3

Interventions

Group 1: AREDS2 (Lutax AMD of Santen Pharmaceutical Co Ltd) oral dietary supplement with a daily dose of 3 capsules (25 mg Zinc) for a Minimum of 15 days up to a maximum of 60 days Group 2: No dietary

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: - Male and female patients = 60 years of age who are able to give written informed consent - Presence of dry or neovascular AMD - Independent recommendation to receive intravitreal surgery or intravitreal injection therapy - Willingness and ability to provide informed consent

Exclusion criteria

Exclusion criteria: - Continued dietary supplementation with AREDS2 dietary supplement or analogue up to 8 weeks before inclusion in the study - Any previous intraocular surgery (apart from cataract removal) in the last 12 months. - Ocular disorders in the study eye other than AMD that may confound interpretation of study results - Diabetes mellitus (type 1 or 2) - History of intravitreal corticosteroids - Systemic inflammatory disease - Diseases known to affect complement activation

Design outcomes

Primary

Measure	Time frame
To demonstrate that inflammation mediator levels of the complement system in aqueous humour of the eye in patients with AMD - measured as the concentration of the complement factor 3a - are influenced by an oral substitution of 25mg of Zinc as part of the AREDS2 dietary Supplementation between basline and follow-up visits.	—

Secondary

Measure	Time frame
To investigate possible correlations between complement activation in aqueous humour as well as blood of patients with AMD.	—

Countries

Germany

Contacts

Public ContactPhilip Enders

Zentrum für Augenheilkunde der Uniklinik Köln

makuladegeneration@uni-koeln.de0221-48-4308

Outcome results

None listed

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