Condition category
Eye Diseases
Date applied
24/05/2007
Date assigned
12/06/2007
Last edited
24/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eric Souied

ORCID ID

Contact details

Service d'Ophtalmologie
Hôpital intercommunal de Créteil
40
Avenue de Verdun
Créteil
94000
France

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

Sponsor information

Organisation

Laboratoire Chauvin, Bausch & Lomb Inc. (France)

Sponsor details

416
Rue Samuel Morse
CS 99535
Montpellier cedex 2
34961
France

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes

24/02/2016: Publication reference added.