Age-related macular degeneration Eye Diseases Other retinal disorders
Conditions
Interventions
Group 1: MZ 10 mg
L 10 mg
Z 2 mg (intervention group 1)
Group 2: 10 mg L plus an additional contamination of circa 1 mg Z (intervention group 2)
The treatment will be 12 months in duration and visits for the trial will be bas
Sponsors
Howard Foundations Holdings Limited (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 50 years and above 2. Early stage AMD in at least one eye 3. No additional ocular pathology to AMD
Exclusion criteria
Exclusion criteria: 1. Cigarette smokers 2. Currently taking dietary supplements and/or had been taking dietary supplements over the previous three months prior to their baseline study visit 3. Diabetics (HbA1c above 6.5%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline, three months, six months and twelve months: 1. Morphological changes in AMD, with respect to baseline and between groups 1 and 2 over the study period 2. MP optical density (including its entire spatial profile), as measured by heterochromatic flicker photometry (HFP) 3. Comparison of MP optical density response between groups 1 and 2 over the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, three months, six months and twelve months: 1. Serum MZ, L and Z concentrations as measured by high-performance liquid chromatography (HPLC) 2. Comparison of serum carotenoid response between groups 1 and 2 over the study period 3. Assessment of retinal sensitivity using microperimetry | — |
Countries
Ireland
Outcome results
None listed