Condition category
Eye Diseases
Date applied
26/03/2009
Date assigned
23/04/2009
Last edited
18/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christian Corbe

ORCID ID

Contact details

Institution des Invalides
6 Boulevard des Invalides
Paris
75007
France

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

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 trial start date

19/03/1999

Overall trial 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

Patient

Age group

Senior

Gender

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

Trial 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

http://www.servier.com/

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.

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.

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

http://clinicaltrials.servier.com/wp-content/uploads/MC3-06790-001_synopsis_report.pdf

Publication list

Publication citations

Additional files

Editorial Notes

18/04/2018: Internal review. 28/03/2018: Publication plan and IPD sharing statement updated. 25/01/2018: Publication plan and IPD sharing statement added. 19/12/2017: results summary added.