A Pilot study investigating the use of Intravitreal Triamcinolone prior to macular laser for Clinically Significant Diabetic Macular Oedema - CSMO and triamcinolone

Conditions: Macular oedema affects 29% of diabetic patients and is the main cause of visual impairment. Previous studies show that diffuse macular oedema carries a particularly poor prognosis despite laser photocoagulation.

Registration Number: EUCTR2004-005043-97-GB

Lead Sponsor: St Mary's NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

Inclusion Criteria

1) Diabetes Mellitus
2) Clinically significant macular oedema as defined by the ETDRS studies
3) Visual Acuity worse than 6/12 (0.3 LogMAR)
4) OCT thickness greater than 300um

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Retinal pathology other than that due to Diabetes
2) Glaucoma, ocular hypertension or known steroid responder
3) Previous laser treatment
4) Only eyes
5) Visual acuity better than 6/12
6) Proliferative diabetic retinopathy
7) Unable to attend for follow up
8) Unfit for a local anaesthetic (LA) procedure
9) Unable to consent fully

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does intravitreal triamcinolone 1 month prior to focal laser improve the visual outcome (using ETDRS charts) compared with focal laser alone in patients with diabetic clinically significant macular oedema (CSMO).<br><br>;Secondary Objective: The effect of treatment on macular thickness using ocular computerised tomography (OCT) and vascular leakage on fluorescein angiography (FFA).;Primary end point(s): Following laser treatment patients will be seen at 3 monthly intervals.<br>Expected duration of participation: 2 Years<br><br>Primary outcome measures at these time points will be changes in visual acuity (using ETDRS charts), near vision and contrast sensitivity.<br>

Secondary Outcome Measures