Randomised Controlled Trial of Intravitreal Triamcinolone in Patients with Diabetic Macular Oedema Refractory to Laser Treatment
| ISRCTN | ISRCTN90614292 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90614292 |
| Secondary identifying numbers | N0192133909 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 13/04/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr S A Vernon
Scientific
Scientific
B Floor
The Eye & ENT Unit
University Hospital
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 924 9924 |
|---|---|
| stephen.vernon@nuh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Does principal intravitreal injection of triamcinolone help in treating diabetic patients with clinically significant macular oedema that is refractory to the conventional focal or grid laser photocoagulation? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Diabetic macular oedema |
| Intervention | 1. Intravitreal injection of tiamcinolone 2. Placebo As of March 2008: trial abandoned due to poor recruitment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Triamcinolone |
| Primary outcome measure | Pre-injection and then month 1, 3 and 6 1. Best corrected visual acuity (logarithm of the minimum angle of resolution [logMAR]) at each visit. A change in either direction of 10 letters on the logMAR chart would be considered significant 2. Near vision tested with a standard add on each visit, with time taken to read the standard N paragraph and the number of mistakes made 3. Intra-ocular pressure at each visit - measured by standard applanation tonometry |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 28/11/2003 |
| Completion date | 01/07/2006 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 28/11/2003 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
B Floor
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Queen's Medical Centre University Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
