Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NAT 2
Study information
Scientific title
Double-masked, randomized, parallel, comparative study of oral supplementation with DecosaHexaenoic Acid (DHA) versus placebo in the prevention of age-related macular degeneration
Acronym
Study hypothesis
Oral supplementation of DHA is able to delay the occurrence of neovessels in the fellow eye of patients already presenting neovascular age-related macular degeneration in one eye
Ethics approval
Committee for the Protection of Persons (CPP) Ile de France 5 Paris (formerly Comités de Consultation pour la Protection des Personnes se prêtant à la Recherche Biomédicale [CCPPRB] Paris Saint Antoine), 22/07/2003
Study design
Randomized double-masked placebo-controlled single-centre study on two parallel groups
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Macular degeneration
Intervention
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 per day [2 capsules at midday and 1 capsule in evening]) for 3 years
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Time to occurrence of choroidal new vessels in the study eye from prospective assessment of fluorescein angiography
Secondary outcome measures
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
Overall trial start date
23/12/2003
Overall trial end date
30/11/2008
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
300
Participant 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)
Recruitment start date
23/12/2003
Recruitment end date
30/11/2008
Locations
Countries of recruitment
France
Trial participating centre
Hôpital intercommunal de Créteil
Créteil
94000
France
Funders
Funder type
Industry
Funder name
Laboratoire Chauvin, Bausch and Lomb group (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26132079
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26901353