Condition category
Eye Diseases
Date applied
01/07/2005
Date assigned
25/07/2005
Last edited
12/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes