Status:
COMPLETED
A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema
Lead Sponsor:
University of Sydney
Collaborating Sponsors:
The University of Western Australia
University of Melbourne
Conditions:
Diabetic Macular Oedema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study is likely to identify an improved and economical treatment for diabetic macular oedema, one of the commonest causes of blindness both in Australia and the rest of the world.The specific aim...
Detailed Description
A 25 fold increase in the risk of going blind on diagnosis of diabetes is one of the most daunting threats that people with diabetes face. Stimulated by several uncontrolled, anecdotal reports, we are...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Diagnosis of diabetes mellitus types 1 or 2
- Diabetic macular oedema affecting the fovea in one or both eyes (phakic or pseudophakic) for which laser treatment is indicated in the opinion of the investigator
- Best corrected visual acuity of 19-68 letters (6/12 -6/120)
- Definite macular oedema on clinical examination involving the centre of the macula
- Retinal thickness \> 250 micron in central 1mm subfield on OCT
- Investigator is comfortable deferring macular laser treatment for 6 weeks
Exclusion
- Glaucoma which is uncontrolled or is controlled but with glaucomatous field defects
- Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion)
- Macular oedema due to other causes including vitreous traction
- An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy)
- Previous treatment IVTA within 6 months or with peribulbar TA within 3 months
- Cataract surgery within the last 6 months
- Retinal laser treatment within the last 4 months
- High risk PDR at baseline or laser therapy cannot be delayed for 6 weeks on retina
- History of herpes viral disease in study eye
- Media opacity including cataract that already precludes adequate macular photography and laser treatment, or cataract that is likely to preclude an adequate view within 2 years
- Known allergies to triamcinolone acetate
- Patient is already receiving systemic steroid treatment
- Intercurrent severe disease such as septicemia, any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social)
- History of chronic renal failure requiring dialysis or renal transplant
- Blood pressure \>180/110 mmHg
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00148265
Start Date
April 1 2005
End Date
May 1 2009
Last Update
June 23 2010
Active Locations (1)
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1
Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney
Sydney, New South Wales, Australia, 2000