Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
MC3-06790-001
Study information
Scientific title
Study of the effect of trimetazidine MR 35 mg (2 tabs/day) on the emergence of choroidal neovascularisation in age-related macular degeneration: a multicentre, randomised, double-blind, placebo-controlled, phase III study in 1100 patients treated for 3 to 5 years
Acronym
France DMLA 2
Study hypothesis
To demonstrate a difference between trimetazidine 35 mg and placebo on the emergence of choroidal neovascularisation.
Ethics approval(s)
Ethics approval was obtained before recruitment of the first participants
Study design
Randomised double-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Aged-related macular degeneration
Intervention
Oral administration of trimetazidine 35 mg or placebo during 3 to 5 years.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Trimetazidine MR
Primary outcome measure
Effect on choroidal neovascularisation evaluated each year.
Secondary outcome measures
1. Effect of the serous drusen evaluated each year
2. Evaluation of pigment epithelium lesion evaluated each year
3. Clinical acceptability of trimetazidine evaluated each 6 months
Overall study start date
19/03/1999
Overall study end date
31/10/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female
2. Caucasian
3. Aged 55 to 83 years with age-related macular degeneration
4. Neovascularisation on the first eye
Participant type(s)
Patient
Age group
Senior
Sex
Both
Target number of participants
1100 participants
Participant exclusion criteria
1. Cataract
2. Diabetic retinopathy
3. Optical neuropathy
4. Neovascularisation on the studied eye
Recruitment start date
19/03/1999
Recruitment end date
31/10/2005
Locations
Countries of recruitment
Belgium, France, Spain
Study participating centre
Institution des Invalides
PARIS
75007
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Summary results are published in https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
Intention to publish date
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |