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Clinical Trials/EUCTR2004-005043-97-GB
EUCTR2004-005043-97-GB
Active, not recruiting
Not Applicable

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

St Mary's NHS Trust0 sites50 target enrollmentApril 5, 2005

Overview

Phase
Not Applicable
Intervention
Not specified
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.
Sponsor
St Mary's NHS Trust
Enrollment
50
Status
Active, not recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 5, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
St Mary's NHS Trust

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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