Contact information
Type
Scientific
Primary contact
Mr S A Vernon
ORCID ID
Contact details
B Floor
The Eye & ENT Unit
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924
stephen.vernon@nuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192133909
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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 names
Triamcinolone
Primary outcome measures
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 trial start date
28/11/2003
Overall trial end date
01/07/2006
Reason abandoned
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
28/11/2003
Recruitment end date
01/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
B Floor
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Queen's Medical Centre University Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary