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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005043-97-GB

Enrollment

Registered

2005-04-05

Start date

2005-06-30

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Kenalog Product Name: Triamcinolone Acetonide Pharmaceutical Form: Injection* INN or Proposed INN: Triamcinolone Acetonide Concentration unit: mg/ml milligram(s)/millilitre Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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). ;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. Expected duration of participation: 2 Years Primary outcome measures at these time points will be changes in visual acuity (using ETDRS charts), near vision and contrast sensitivity.	—

Measure

Time frame

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). ;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. Expected duration of participation: 2 Years Primary outcome measures at these time points will be changes in visual acuity (using ETDRS charts), near vision and contrast sensitivity.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026