ACTRN12611001210965CompletedPhase 2
An open label phase II/III clinical trial of Ranibizumab on the effects and safety for diabetic macular oedema resistant to intravitreal triamcinolone (TAREDS)
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- the University of Sydney
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •All patient with diabetic macular oedema resistant to IVTA treatment.
- •IVTA resistance is defined as
- •- An improvement in VA of less than 5 letters
- •- A reduction in central retinal thickness in OCT of less than 100 microns
- •(or less than 20%, whichever is greater) 6 weeks after treatment with IVTA for at least 2 consecutive injections.
Exclusion Criteria
- •- loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration)
- •- no useful vision in fellow eye
- •- cataract surgery or retinal laser within 1st six months of entering the study
- •- uncontrolled systemic disease including blood pressure>180/110
Investigators
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