An Open Label Clinical Trial of Ranibizumab for Diabetic Macular Oedema resistant to Intravitreal Triamcinolone

Phase 2

Completed

• Conditions: Diabetic macular oedema; Metabolic and Endocrine - Diabetes; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12611001210965
• Lead Sponsor: the University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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
AND
- 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

Patients
- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified