Age-Related Macular DegenerationNCT00879671
Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
A study testing lutamax (leutein) in people with Age-Related Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- lutamax (leutein)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2006to May 2011
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with nonexudative AMD (either categories 2, 3 or 4 according to the AREDS criteria; in group 4 the eyes with no-advanced AMD will be included, Age-Related Eye Disease Study Research Group 2001)
- Age between 50 and 90 years
- Clear non-lenticular ocular media
- Visual acuity > 0.4
Who cannot join
- Primary retinal pigment epithelium atrophy > 125 µm
- Moderate or severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy
- Participation in a clinical trial in the 3 weeks preceding the study
- Previous treatment with lutein within 3 month of study initiation
- History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
- Ocular surgery within the last 6 months
- Treatment with photosensitizing drugs
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna
About this study
The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that this absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.
Age-related macular degeneration is the leading cause of blindness among developed countries. The pathogenesis of this disease remains unknown. There is, however, evidence that low fruit and vegetable consumption increases the risk of Age-Related Macular Degeneration (AMD). Accordingly, it has been hypothesized that lutein supplementation may be beneficial in AMD. The present study investigates whether 6 months lutein supplementation increases MP optical density (OD), influences visual acuity, depth and dimension of central scotoma and alters symptoms in patients with AMD.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- lutamax (leutein), placebo
- Keywords
- lutein, nonexudative AMD, MPOD, Supplementary Concepts
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lutamax (leutein)Dietary supplement
leutein 20 mg for 3 months, then lutein 10 mg
placeboDietary supplement
Placebo capsules identical in taste and appearance
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lutamax Receives: Dietary Supplement: lutamax (leutein) |
| 2 | Placebo comparator | Placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular pigment optical density (MPOD) as measured with optical reflectometry
Measured: 5 minutes
Secondary outcomes (4)
Visual acuity using ETDRS charts
Measured: 15 minutes
Central visual field defects assessed with scanning laser scotometry
Measured: 30 minutes
Changes in fundus appearance as documented with fundus photos
Measured: 5 minutes
Determination of an increased systemic antioxidative state in plasma and low density lipoprotein and Plasma lutein concentrations
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startNov 2006
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Ursula Schmidt-Erfurth, Prof. Dr., Principal investigator, Department of Opthalmology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879671
- Sponsor's protocol ID
- OPHT-100205
- Status last verified
- Nov 2014
- First submitted
- 9 Apr 2009
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
PubMed 37702300Weigert G, Kaya S, Pemp B, Sacu S, Lasta M, Werkmeister RM, Dragostinoff N, Simader C, Garhofer G, Schmidt-Erfurth U, Schmetterer L. Effects of lutein supplementation on macular pigment optical density and visual acuity in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8174-8. doi: 10.1167/iovs.11-7522.
PubMed 21873668
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00879671
- Acronym / sponsor ID
- OPHT-100205
- Conditions
- Age-Related Macular Degeneration
- Keywords
- lutein, nonexudative AMD, MPOD, Supplementary Concepts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Apr 2009 (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.
The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that this absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.
Age-related macular degeneration is the leading cause of blindness among developed countries. The pathogenesis of this disease remains unknown. There is, however, evidence that low fruit and vegetable consumption increases the risk of Age-Related Macular Degeneration (AMD). Accordingly, it has been hypothesized that lutein supplementation may be beneficial in AMD. The present study investigates whether 6 months lutein supplementation increases MP optical density (OD), influences visual acuity, depth and dimension of central scotoma and alters symptoms in patients with AMD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: lutamax (leutein)Lutamax |
| 2 | Placebo comparator | Dietary Supplement: placeboPlacebo |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with nonexudative AMD (either categories 2, 3 or 4 according to the AREDS criteria; in group 4 the eyes with no-advanced AMD will be included, Age-Related Eye Disease Study Research Group 2001)
- Age between 50 and 90 years
- Clear non-lenticular ocular media
- Visual acuity > 0.4
Key exclusion criteria (8 listed)
- Primary retinal pigment epithelium atrophy > 125 µm
- Moderate or severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy
- Participation in a clinical trial in the 3 weeks preceding the study
- Previous treatment with lutein within 3 month of study initiation
- History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
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 |
|---|---|---|
| lutamax (leutein)leutein 20 mg for 3 months, then lutein 10 mg | Dietary supplement | 1 |
| placeboPlacebo capsules identical in taste and appearance | Dietary supplement | 2 |
Primary outcome
Macular pigment optical density (MPOD) as measured with optical reflectometry
Time frame: 5 minutes
4 secondary outcomes
Visual acuity using ETDRS charts
Time frame: 15 minutes
Central visual field defects assessed with scanning laser scotometry
Time frame: 30 minutes
Changes in fundus appearance as documented with fundus photos
Time frame: 5 minutes
Determination of an increased systemic antioxidative state in plasma and low density lipoprotein and Plasma lutein concentrations
Time frame: 5 minutes
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 14 Nov 2014.
- Derived from this study: PubMed 37702300Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
- Derived from this study: PubMed 21873668Weigert G, Kaya S, Pemp B, Sacu S, Lasta M, Werkmeister RM, Dragostinoff N, Simader C, Garhofer G, Schmidt-Erfurth U, Schmetterer L. Effects of lutein supplementation on macular pigment optical density and visual acuity in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8174-8. doi: 10.1167/iovs.11-7522.
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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.
Ursula Schmidt-Erfurth, Prof. Dr. principal investigator
Department of Opthalmology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lutamax (leutein) in people with Age-Related Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
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 8 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 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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. Some participants in this study may receive a placebo. 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?
Macular pigment optical density (MPOD) as measured with optical reflectometry (time frame: 5 minutes). 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 NCT00879671, which also lists 2 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 14 Nov 2014.