The putative beneficial effects of supplemental Lutein (L) and Zeaxanthin (Z) with co-antioxidants in patients with age-related maculopathy: A pilot short term randomised controlled clinical trial of antioxidant supplementation
| ISRCTN | ISRCTN94557601 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94557601 |
| Secondary identifying numbers | DMP628.1.03 |
- Submission date
- 01/07/2005
- Registration date
- 25/07/2005
- Last edited
- 12/12/2012
- 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 Usha Chakravarthy
Scientific
Scientific
Ophthalmology and Vision Science
Institute of Clinical Science
Queen's Univerisity of Belfast
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
| Phone | +44 (0)28 90633955 |
|---|---|
| u.chakravarthy@qub.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study acronym | CARMA |
| Study objectives | Subjects aged 50 years and older with evidence of early ARM in both eyes or advanced AMD in one eye. The primary hypothesis is that progression from early ARM to late AMD may be delayed or prevented through supplementation with key antioxidants (vitamins, minerals and carotenoids) which are either known to be present in high concentrations in healthy neural retina/retinal pigment epithelium (RPE)/choroidal interface or are free radical scavengers and thus have potential protective roles in minimisation of oxidative stress. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Age-related maculopathy |
| Intervention | Daily oral administration of supplement - Lutein + Zeaxanthin + Vitamin E + C + Zn/Cu tablet per day (to be known as CARMA Preparation) Control: Placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lutein, Zeaxanthin, co-antioxidants |
| Primary outcome measure | The primary outcome will be retinal acuity in the study eye at 12 months of supplementation. The level of significance for changes will be set at 0.05. |
| Secondary outcome measures | 1. Change in distance visual acuity (DVA) in treatment and control groups at 12 months. Similar to the primary outcome the level of significance for changes will be set at 0.05. 2. Progression of ARM based on detailed grading of stereo colour fundus images. Progression is defined as a change of at least one step in the level of severity as gauged by the appearance or an increase in (a) drusen (size, frequency and extent), (b) focal hyper or hypopigmentation (area). 3. In vivo macular carotenoid signal strength. 4. Serum markers Vitamin C, lipid soluble vitamins, cholesterol. Data from all patients who continued supplementation for more than 12 months will be collected and analysed in order get as much information as possible regarding the changes of visual function during the duration of the study. These additional data will be analysed independently from the primary and secondary outcomes at 12 months of supplementation. |
| Overall study start date | 01/06/2004 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 360 |
| Key inclusion criteria | 1. Patient must be willing to give written informed consent, make the required study visits, and follow instructions 2. Patient must be at least 50 years of age 3. Patients may be of any race or sex 4. Two groups of ARM patients may be included Group 1: If there is choroidal neovascularisation (CNV) or geographic atrophy (GA) in one eye, any level of ARM is permissible in the fellow eye provided visual acuity (VA) is equal to or better than logarithm of the minimum angle of resolution (logMAR) 0.3 Group 2: Clinical diagnosis of severe early ARM in at least one eye. ≥20 soft distinct or soft indistinct drusen or if fewer that 20 soft drusen, focal hyper pigmentation must be present. Visual acuity greater than or equal to 6/12 or 0.3 logMAR in the study eye (which may be both eyes). |
| Key exclusion criteria | 1. Any retinal laser therapy in the study eye 2. In Group 1 there should be no visible choroidal neovascularisation or geographic atrophy 3. History of any unstable medical condition or life threatening conditions, for example, cancer or renal failure, that would preclude scheduled study visits or completion of the study 4. History of ophthalmic disease in the study eye (other than ARM) that would compromise the visual acuity of the study eye 5. Patients currently on supplements containing the antioxidants C, E, Zn, L and Z will be asked to discontinue them and may, after a washout period of three months, be eligible for randomisation into the study 6. History of malabsorption 7. History of psychiatric disorder, which may interfere with compliance in taking study medication or attendance for study visits 8. Patients with known allergy against one of the active ingredients or the other excipients in the study medications |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Ophthalmology and Vision Science
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Dr. Mann Pharma GmbH, Bausch & Lomb Group (Germany)
Industry
Industry
Brunsbuetteler damm 165
Berlin
13581
Germany
| Phone | +49 (0)30 33093329 |
|---|---|
| annette.schappach@bausch.com | |
"ROR" |
https://ror.org/049ncrn81 |
Funders
Funder type
Industry
Dr Mann Pharma, Bausch and Lomb and Chauvin Group Berlin, Germany
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? |
|---|---|---|---|---|---|
| Other publications | design and methods | 01/11/2008 | Yes | No | |
| Results article | results | 01/09/2011 | Yes | No | |
| Results article | results | 01/03/2013 | Yes | No |
