Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema that Persists after Laser Treatment (TDMO)

Phase 2

Completed

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

• Registration Number: ACTRN12605000211662
• Lead Sponsor: Professor Mark Gillies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Clinically significant diabetic macular oedema involving the fovea in one or both eyes (phakic and/or pseudophakic) which persists at least 3 months after adequate macular photocoagulation. Best corrected visual acuity in the affected eye(s) 6/9 or worse.

Exclusion Criteria

Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field defects. Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration). Significant macular ischemia (FFA). No useful vision in fellow eye. Known allergies to triamcinolone acetate or steroids. Patient is already under systemic treatment with > 5mg prednisolone (or equivalent) daily. Intercurrent severe disease such as septicaemia. Any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of treated versus untreated eyes with improvement of visual acuity by 5 letters or more on the ETDRS chart[At 24 months, no less than 3 months after the most recent treatment episode.<br><br>An interim analysis of the primary and secondary outcomes will be performed on data collected at the 3 month study visit.];Incidence of moderate or severe adverse effects related to treatment[An interim analysis of the primary and secondary outcomes will be performed on data collected at the 3 month study visit.]

Secondary Outcome Measures

Name	Time	Method
Any change of visual acuity (treated versus untreated eyes).[At 3 months and 24 months after treatment.];Proportion of treated versus untreated eyes with reduction of macular thickness as demonstrated with OCT[At 3 months and 24 months.];Both absolute change and percentage change will be analysed. Comparisons between treatment groups will include mean change as well as proportion with absolute decreases of > 75µm, > 100µm and > 200µm and percentage decreases of > 25%, > 50%, and > 75%. Changes in semi-quantitative grading of cataract[At 3 months and 24 months.]