Double-masked, randomized, parallel, comparative study of oral supplementation with DecosaHexaenoic Acid (DHA) versus placebo in the prevention of age-related macular degeneratio
- Conditions
- Macular degenerationEye Diseases
- Registration Number
- ISRCTN98246501
- Lead Sponsor
- aboratoire Chauvin, Bausch & Lomb Inc. (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
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)
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method