Contact information
Type
Scientific
Primary contact
Prof Usha Chakravarthy
ORCID ID
Contact details
Ophthalmology and Vision Science
Institute of Clinical Science
Queen's Univerisity of Belfast
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
+44 (0)28 90633955
u.chakravarthy@qub.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DMP628.1.03
Study information
Scientific title
Acronym
CARMA
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/06/2004
Overall trial end date
01/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
360
Participant 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
Recruitment start date
01/06/2004
Recruitment end date
01/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ophthalmology and Vision Science
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Dr. Mann Pharma GmbH, Bausch & Lomb Group (Germany)
Sponsor details
Brunsbuetteler damm 165
Berlin
13581
Germany
+49 (0)30 33093329
annette.schappach@bausch.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dr Mann Pharma, Bausch and Lomb and Chauvin Group Berlin, Germany
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
Basic results (scientific)
Publication list
1. 2008 design and methods in http://www.ncbi.nlm.nih.gov/pubmed/19065432
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21610564
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23218821
Publication citations
-
Design and methods
Neelam K, Hogg RE, Stevenson MR, Johnston E, Anderson R, Beatty S, Chakravarthy U, Carotenoids and co-antioxidants in age-related maculopathy: design and methods., Ophthalmic Epidemiol, 15, 6, 389-401, doi: 10.1080/09286580802154275.
-
Results
Lai Y, Grattan J, Shi Y, Young G, Muldrew A, Chakravarthy U, Functional and morphologic benefits in early detection of neovascular age-related macular degeneration using the preferential hyperacuity perimeter., Retina (Philadelphia, Pa.), 2011, 31, 8, 1620-1626, doi: 10.1097/IAE.0b013e31820d3ed1.
-
Results
Beatty S, Chakravarthy U, Nolan JM, Muldrew KA, Woodside JV, Denny F, Stevenson MR, Secondary outcomes in a clinical trial of carotenoids with coantioxidants versus placebo in early age-related macular degeneration., Ophthalmology, 2013, 120, 3, 600-606, doi: 10.1016/j.ophtha.2012.08.040.