Exudative Age-related Macular DegenerationNCT01404845
Macular Pigment Density Evolution in Unilateral Wet AMD Versus Non AMD Patients With or Without Lutein and Zeaxanthine Supplementation
A study testing Nutrof Total and food supplement without Lutein and Zeaxanthin in people with Exudative Age-related Macular Degeneration, run by Affordance at 2 sites in France.
Trial summary
•Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and visual impairment in industrialized countries. The macular pigment, composed of carotenoid derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Exudative Age-related Macular Degeneration
- What is being tested?
- Nutrof Total and food supplement without Lutein and Zeaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2011to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders (male or female), ≥ 55 years of age.
- Patients without any retinal pathology who underwent cataract surgery 1 month previously Or
- Patients with neovascular AMD (Age-related macular Degeneration) in one eye.
- Patients who gave their written consent
Who cannot join
- Intolerance to the tested product
- Change in fundus image
- Patients already taking Nutrof Total or similar supplements containing Lutein and Zeaxanthin
- Allergy to mydriatics
- o Ocular diseases or conditions whose presence might interfere with the measurement of optical density of macular pigment (e.g. cataract, diabetic retinopathy, optic atrophy, myopia> -6.5 Diopters)
- o Medical or surgical history, disorder or disease (e.g. severe organic disease, acute or chronic: liver disease, endocrine, neoplastic, hematologic, infectious diseases, severe psychiatric disorder, significant cardiovascular abnormalities, etc...) and / or aggravating factors or structural defect, considered as being inconsistent with the study by the investigator.
Show all 10Show fewer
- Inability of the patient to understand the study procedures and to give informed consent.
- Ward of court
- Patient not covered by the social security scheme
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites
Docteur Jean-Jacques Masella
Grenoble, 38000
Centre ophtalmologique Rabelais
Lyon, 69003
About this study
Official title: Assessment of the Evolution of Macular Pigment Density in Two Distinct Populations, Before and After Supplementation With Nutrof Total Versus Dietary Supplement Without Lutein and Zeaxanthin, Using the Macular Pigment Module of Visucam 200 or Visucam 500 (Zeiss).
•Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and visual impairment in industrialized countries. The macular pigment, composed of carotenoid derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An increase in macular pigment following dietary supplementation with lutein and zeaxanthin could allow early treatment with such supplements in subjects with a high risk of AMD, and encourage them to change their eating habits.
•Primary outcome:
Read more
Comparative analysis of the density and evolution of the density of macular pigment:
- In patients without any retinal pathology who underwent cataract surgery 1 month previously
- In the non-exudative eye of patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye
- Secondary outcomes:
Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator):
- Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements)
- Time taken to return to the baseline macular pigment density after cessation of supplementation
- Study design :
Pilot study -Prospective, randomised, double-masked, comparative, multicenter.
- Being tested
- Nutrof Total, food supplement without Lutein and Zeaxanthin
- Keywords
- exudative AMD, dietary supplements, macular pigment, lutein, zeaxanthin, Nutrof total, in one eye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrof TotalDietary supplement
Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).
food supplement without Lutein and ZeaxanthinDietary supplement
food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.
| Study group | Role | What they receive |
|---|---|---|
| B: patients with wet AMD in one eye. | Active comparator | group B: patients with wet AMD in one eye. In each group, A and B, half the patients will be randomized in a subgroup to Nutrof Total, and the other half in a subgroup to a food supplement not containing Lutein and Zeaxanthin. Receives: Dietary Supplement: Nutrof Total; Dietary Supplement: food supplement without Lutein and Zeaxanthin |
| A :patients without retinal pathology | Active comparator | group A :patients without retinal pathology who underwent cataract surgery 1 month previously.
In each group, A and B, half the patients will be randomized in a subgroup to Nutrof Total, and the other half in a subgroup to a food supplement not containing Lutein and Zeaxanthin. Receives: Dietary Supplement: Nutrof Total; Dietary Supplement: food supplement without Lutein and Zeaxanthin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative analysis of macular pigment density
Comparative analysis of macular pigment density in patients who underwent cataract operation 1 month ago, without retinal pathology and in patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye.
Optical density (OD)parameters of the macular pigments measured by an objective reflectometry method based on a 30° field image acquired by the Visucam 200 or 500 of Zeiss :
Area : where macular pigments could be detected
Max OD/Mean OD/ Volume : Maximum value/Mean Value/Sum of all OD in the area
Measured: 18 months
Secondary outcomes (1)
Analysis of changes in macular pigment density
Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator):
- Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements)
- Time taken to return to the baseline macular pigment density after cessation of supplementation
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Exudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affordance
- Sponsor type
- Research network
- Collaborators
- Drescode
- Responsible party
- Sponsor
- Investigators
- Martine Mauget-faysse, Principal investigator, Affordance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404845
- Sponsor's protocol ID
- 2011-A00922-39
- Status last verified
- Jun 2015
- First submitted
- 22 Jul 2011
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
PubMed 15640920Delcourt C. Epidémiologie de la DMLA dans la population française. In: Soubrane G, Coscas G, Souied EH, editors. Les DMLAs (9ème édition). Rapport de la Société Française d'Ophtalmologie. Paris: Masson; 2007. p. 108-110.
Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med. 2008 Jun 12;358(24):2606-17. doi: 10.1056/NEJMra0801537. No abstract available.
PubMed 18550876Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001 Oct;119(10):1417-36. doi: 10.1001/archopht.119.10.1417.
PubMed 11594942Whitehead AJ, Mares JA, Danis RP. Macular pigment: a review of current knowledge. Arch Ophthalmol. 2006 Jul;124(7):1038-45. doi: 10.1001/archopht.124.7.1038.
PubMed 16832030Antioxidant status and neovascular age-related macular degeneration. Eye Disease Case-Control Study Group. Arch Ophthalmol. 1993 Jan;111(1):104-9. doi: 10.1001/archopht.1993.01090010108035.
PubMed 7678730Gale CR, Hall NF, Phillips DI, Martyn CN. Lutein and zeaxanthin status and risk of age-related macular degeneration. Invest Ophthalmol Vis Sci. 2003 Jun;44(6):2461-5. doi: 10.1167/iovs.02-0929.
PubMed 12766044Delcourt C, Carriere I, Delage M, Barberger-Gateau P, Schalch W; POLA Study Group. Plasma lutein and zeaxanthin and other carotenoids as modifiable risk factors for age-related maculopathy and cataract: the POLA Study. Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2329-35. doi: 10.1167/iovs.05-1235.
PubMed 16723441Tan JS, Wang JJ, Flood V, Rochtchina E, Smith W, Mitchell P. Dietary antioxidants and the long-term incidence of age-related macular degeneration: the Blue Mountains Eye Study. Ophthalmology. 2008 Feb;115(2):334-41. doi: 10.1016/j.ophtha.2007.03.083. Epub 2007 Jul 30.
PubMed 17664009Cho E, Hankinson SE, Rosner B, Willett WC, Colditz GA. Prospective study of lutein/zeaxanthin intake and risk of age-related macular degeneration. Am J Clin Nutr. 2008 Jun;87(6):1837-43. doi: 10.1093/ajcn/87.6.1837.
PubMed 18541575VandenLangenberg GM, Mares-Perlman JA, Klein R, Klein BE, Brady WE, Palta M. Associations between antioxidant and zinc intake and the 5-year incidence of early age-related maculopathy in the Beaver Dam Eye Study. Am J Epidemiol. 1998 Jul 15;148(2):204-14. doi: 10.1093/oxfordjournals.aje.a009625.
PubMed 9676703Cho E, Seddon JM, Rosner B, Willett WC, Hankinson SE. Prospective study of intake of fruits, vegetables, vitamins, and carotenoids and risk of age-related maculopathy. Arch Ophthalmol. 2004 Jun;122(6):883-92. doi: 10.1001/archopht.122.6.883.
PubMed 15197064Beatty S, Murray IJ, Henson DB, Carden D, Koh H, Boulton ME. Macular pigment and risk for age-related macular degeneration in subjects from a Northern European population. Invest Ophthalmol Vis Sci. 2001 Feb;42(2):439-46.
PubMed 11157880Bone RA, Landrum JT, Mayne ST, Gomez CM, Tibor SE, Twaroska EE. Macular pigment in donor eyes with and without AMD: a case-control study. Invest Ophthalmol Vis Sci. 2001 Jan;42(1):235-40.
PubMed 11133874Bernstein PS, Zhao DY, Wintch SW, Ermakov IV, McClane RW, Gellermann W. Resonance Raman measurement of macular carotenoids in normal subjects and in age-related macular degeneration patients. Ophthalmology. 2002 Oct;109(10):1780-7. doi: 10.1016/s0161-6420(02)01173-9.
PubMed 12359594
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Evolution of Macular Pigment Density in Two Distinct Populations, Before and After Supplementation With Nutrof Total Versus Dietary Supplement Without Lutein and Zeaxanthin, Using the Macular Pigment Module of Visucam 200 or Visucam 500 (Zeiss).
- ClinicalTrials.gov ID
- NCT01404845
- Acronym / sponsor ID
- 2011-A00922-39
- Keywords
- exudative AMD, dietary supplements, macular pigment, lutein, zeaxanthin, Nutrof total, in one eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AffordanceResearch network
- Collaborators
- Drescode
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
•Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and visual impairment in industrialized countries. The macular pigment, composed of carotenoid derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An increase in macular pigment following dietary supplementation with lutein and zeaxanthin could allow early treatment with such supplements in subjects with a high risk of AMD, and encourage them to change their eating habits.
•Primary outcome:
Comparative analysis of the density and evolution of the density of macular pigment:
- In patients without any retinal pathology who underwent cataract surgery 1 month previously
- In the non-exudative eye of patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye
- Secondary outcomes:
Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator):
- Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements)
- Time taken to return to the baseline macular pigment density after cessation of supplementation
- Study design :
Pilot study -Prospective, randomised, double-masked, comparative, multicenter.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B: patients with wet AMD in one eye. | Active comparator | Dietary Supplement: Nutrof Total, Dietary Supplement: food supplement without Lutein and Zeaxanthingroup B: patients with wet AMD in one eye. In each group, A and B, half the patients will be randomized in a subgroup to Nutrof Total, and the other half in a subgroup to a food supplement not containing Lutein and Zeaxanthin. |
| A :patients without retinal pathology | Active comparator | Dietary Supplement: Nutrof Total, Dietary Supplement: food supplement without Lutein and Zeaxanthingroup A :patients without retinal pathology who underwent cataract surgery 1 month previously. In each group, A and B, half the patients will be randomized in a subgroup to Nutrof Total, and the other half in a subgroup to a food supplement not containing Lutein and Zeaxanthin. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders (male or female), ≥ 55 years of age.
- Patients without any retinal pathology who underwent cataract surgery 1 month previously Or
- Patients with neovascular AMD (Age-related macular Degeneration) in one eye.
- Patients who gave their written consent
Key exclusion criteria (10 listed)
- Intolerance to the tested product
- Change in fundus image
- Patients already taking Nutrof Total or similar supplements containing Lutein and Zeaxanthin
- Allergy to mydriatics
- o Ocular diseases or conditions whose presence might interfere with the measurement of optical density of macular pigment (e.g. cataract, diabetic retinopathy, optic atrophy, myopia> -6.5 Diopters)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrof TotalNutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule). | Dietary supplement | A :patients without retinal pathology, B: patients with wet AMD in one eye. |
| food supplement without Lutein and Zeaxanthinfood supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months. | Dietary supplement | A :patients without retinal pathology, B: patients with wet AMD in one eye. |
Primary outcome
Comparative analysis of macular pigment density
Time frame: 18 months
Comparative analysis of macular pigment density in patients who underwent cataract operation 1 month ago, without retinal pathology and in patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye. Optical density (OD)parameters of the macular pigments measured by an objective reflectometry method based on a 30° field image acquired by the Visucam 200 or 500 of Zeiss : Area : where macular pigments could be detected Max OD/Mean OD/ Volume : Maximum value/Mean Value/Sum of all OD in the area
1 secondary outcome
Analysis of changes in macular pigment density
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Background: PubMed 15640920Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
- BackgroundDelcourt C. Epidémiologie de la DMLA dans la population française. In: Soubrane G, Coscas G, Souied EH, editors. Les DMLAs (9ème édition). Rapport de la Société Française d'Ophtalmologie. Paris: Masson; 2007. p. 108-110.
- Background: PubMed 18550876Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med. 2008 Jun 12;358(24):2606-17. doi: 10.1056/NEJMra0801537. No abstract available.
- Background: PubMed 11594942Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001 Oct;119(10):1417-36. doi: 10.1001/archopht.119.10.1417.
- Background: PubMed 16832030Whitehead AJ, Mares JA, Danis RP. Macular pigment: a review of current knowledge. Arch Ophthalmol. 2006 Jul;124(7):1038-45. doi: 10.1001/archopht.124.7.1038.
- Background: PubMed 7678730Antioxidant status and neovascular age-related macular degeneration. Eye Disease Case-Control Study Group. Arch Ophthalmol. 1993 Jan;111(1):104-9. doi: 10.1001/archopht.1993.01090010108035.
- Background: PubMed 12766044Gale CR, Hall NF, Phillips DI, Martyn CN. Lutein and zeaxanthin status and risk of age-related macular degeneration. Invest Ophthalmol Vis Sci. 2003 Jun;44(6):2461-5. doi: 10.1167/iovs.02-0929.
- Background: PubMed 16723441Delcourt C, Carriere I, Delage M, Barberger-Gateau P, Schalch W; POLA Study Group. Plasma lutein and zeaxanthin and other carotenoids as modifiable risk factors for age-related maculopathy and cataract: the POLA Study. Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2329-35. doi: 10.1167/iovs.05-1235.
- Background: PubMed 17664009Tan JS, Wang JJ, Flood V, Rochtchina E, Smith W, Mitchell P. Dietary antioxidants and the long-term incidence of age-related macular degeneration: the Blue Mountains Eye Study. Ophthalmology. 2008 Feb;115(2):334-41. doi: 10.1016/j.ophtha.2007.03.083. Epub 2007 Jul 30.
- Background: PubMed 18541575Cho E, Hankinson SE, Rosner B, Willett WC, Colditz GA. Prospective study of lutein/zeaxanthin intake and risk of age-related macular degeneration. Am J Clin Nutr. 2008 Jun;87(6):1837-43. doi: 10.1093/ajcn/87.6.1837.
- Background: PubMed 9676703VandenLangenberg GM, Mares-Perlman JA, Klein R, Klein BE, Brady WE, Palta M. Associations between antioxidant and zinc intake and the 5-year incidence of early age-related maculopathy in the Beaver Dam Eye Study. Am J Epidemiol. 1998 Jul 15;148(2):204-14. doi: 10.1093/oxfordjournals.aje.a009625.
- Background: PubMed 15197064Cho E, Seddon JM, Rosner B, Willett WC, Hankinson SE. Prospective study of intake of fruits, vegetables, vitamins, and carotenoids and risk of age-related maculopathy. Arch Ophthalmol. 2004 Jun;122(6):883-92. doi: 10.1001/archopht.122.6.883.
Related trials for Exudative Age-related Macular Degeneration
RecruitingObservational study
Study of Switching to Aflibercept 8 mg in Patients With Refractory or Dependent Exudative Age-related Macular Degeneration
Exudative Age-Related Macular Degeneration
RecruitingObservational study
Ethical Issues of Using Gene Therapy in the Treatment of AMD
Exudative Age-related Macular Degeneration
Not yet recruitingObservational study
Home Monitoring in eAMD Treatment
Exudative Age-Related Macular Degeneration
RecruitingPhase 2
MMP-9 Inhibition for Recalcitrant Wet AMD
Exudative Macular Degeneration, Wet Age-related Macular Degeneration
Active, not recruitingPhase 1
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
Non-exudative Age-related Macular Degeneration, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Mauget-faysse principal investigator
Affordance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrof Total and food supplement without Lutein and Zeaxanthin in people with Exudative Age-related Macular Degeneration, run by Affordance at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative analysis of macular pigment density (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01404845, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015; AzTrials last refreshed its copy on 4 Nov 2026.