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
Protocol serial number	N0192133909
Sponsor	Department of Health
Funder	Queen's Medical Centre University Hospital NHS Trust (UK)

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

Mr S A Vernon
Scientific

B Floor
The Eye & ENT Unit
University Hospital
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 924 9924
Email	stephen.vernon@nuh.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Triamcinolone
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/07/2006
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

B Floor

Nottingham
NG7 2UH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan