Effect of trimetazidine MR 35 mg on the emergence of choroidal neovascularisation in age-related macular degeneration
| ISRCTN | ISRCTN99532788 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99532788 |
| Secondary identifying numbers | MC3-06790-001 |
- Submission date
- 26/03/2009
- Registration date
- 23/04/2009
- Last edited
- 18/04/2018
- 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 and not expected to be available in the future
Contact information
Dr Christian Corbe
Scientific
Scientific
Institution des Invalides
6 Boulevard des Invalides
Paris
75007
France
Study information
| Study design | Randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | France DMLA 2 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 1100 participants |
| Key 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 |
| Key exclusion criteria | 1. Cataract 2. Diabetic retinopathy 3. Optical neuropathy 4. Neovascularisation on the studied eye |
| Date of first enrolment | 19/03/1999 |
| Date of final enrolment | 31/10/2005 |
Locations
Countries of recruitment
- Belgium
- France
- Spain
Study participating centre
Institution des Invalides
PARIS
75007
France
75007
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |
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.
