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)
- Conditions
- H35.3Degeneration of macula and posterior pole
- Registration Number
- DRKS00012507
- Lead Sponsor
- Zentrum für Augenheilkunde der Uniklinik Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 63
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To investigate possible correlations between complement activation in aqueous humour as well as blood of patients with AMD.