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 |
| Protocol serial number | MC3-06790-001 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Trimetazidine MR |
| Primary outcome measure(s) | Effect on choroidal neovascularisation evaluated each year. |
| Key secondary outcome measure(s) | 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 |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 1100 |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
