Condition category
Eye Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes