Double-masked, randomized, parallel, comparative study of oral supplementation with DecosaHexaenoic Acid (DHA) versus placebo in the prevention of age-related macular degeneration
| ISRCTN | ISRCTN98246501 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98246501 |
| Secondary identifying numbers | NAT 2 |
- Submission date
- 24/05/2007
- Registration date
- 12/06/2007
- Last edited
- 24/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Eric Souied
Scientific
Scientific
Service d'Ophtalmologie
Hôpital intercommunal de Créteil
40, Avenue de Verdun
Créteil
94000
France
Study information
| Study design | Randomized double-masked placebo-controlled single-centre study on two parallel groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 23/12/2003 |
| Completion date | 30/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 300 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 23/12/2003 |
| Date of final enrolment | 30/11/2008 |
Locations
Countries of recruitment
- France
Study participating centre
Hôpital intercommunal de Créteil
Créteil
94000
France
94000
France
Sponsor information
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
Industry
Industry
416
Rue Samuel Morse
CS 99535
Montpellier cedex 2
34961
France
"ROR" |
https://ror.org/018qejt38 |
|---|
Funders
Funder type
Industry
Laboratoire Chauvin, Bausch and Lomb group (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2015 | Yes | No | |
| Results article | results | 22/02/2016 | Yes | No |
Editorial Notes
24/02/2016: Publication reference added.
