Macular degeneration Eye Diseases Macular degeneration
Conditions
Interventions
Intervention group:
Oral supplementation with 840 mg of DHA per day (3 capsules per day [2 capsules at midday and 1 capsule in evening]) for 3 years
Control group:
Placebo (olive oil) 3 capsules pe
Sponsors
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients 2. Aged at least 55 years and less than 85 years 3. Having given written informed consent 4. Presenting neovascular age-related macular degeneration in one eye 5. Lesions of age-related maculopathy (confluent and diffuse hard drusen and/or soft drusen with or without pigmentary changes and/or reticular pseudodrusen) 6. Visual acuity of at least +0.4 LogMar (at least 4/10) in the fellow eye (study eye)
Exclusion criteria
Exclusion criteria: 1. Choroidal new vessels in both eyes 2. Wide central area of geographic atrophy encroaching on fovea in the study eye 3. History of other progressive ocular disease, which may complicate the assessment of age-related macular degeneration (severe glaucoma, other severe retinopathy) 4. Opacity precluding evaluation of retina photograph 5. History of serious systemic disease, which may prevent patients? long-term participation in the study 6. Patients treated with anticoagulants or predisposed to bleeding or hemorrhage 7. History of an allergic reaction to fluorescein injection or to indocyanin green 8. Known sensitivity to DHA or vehicle 9. Treatment with Maxepa or DHA within the previous 6 months 10. Treatment with vitamin E 11. Any concomitant nutritional supplementation 12. Involvement in the last 30 days in any other investigational drug study 13. Monocular patients (for any reason other than age-related macular degeneration)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to occurrence of choroidal new vessels in the study eye from prospective assessment of fluorescein angiography | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (in study eye): 1. Percentage of patients for whom new vessels occur during the study 2. Change from baseline in visual acuity in LogMar units and proportion of patients with a visual acuity decrease from baseline of more than 15 letters at Early Treatment Diabetic Retinopathy Study (ETDRS) assessed at 6 months, Year 1, Year 2 and Year 3 3. Change from baseline in visual function assessed with a multi-focal ElectroRetinoGram (ERG) at Year 3 4. Occurrence and progression of drusen (number, size and area) at 6 months, Year 1, Year 2 and Year 3 5. DHA concentration changes in red blood cell membranes at 6 months and Year 3 Safety: 6. Change in slit lamp examination at 6 months, Year 1, Year 2 and Year 3 7. Intra-ocular pressure change from baseline at 6 months, Year 1, Year 2 and Year 3 8. Change from baseline in profile of plasma lipoproteins at 6 months and Year 3 9. Adverse or unexpected events | — |
Countries
France
Outcome results
None listed