Avastin versus Triamcinolone for Diabetic Macular Edema at the time of Cataract Surgery

Randomised, double-masked, controlled trial of intravitreal Avastin (bevacizumab) versus Triesence (triamcinolone) at the time of cataract surgery on the visual outcomes for patients with diabetic macular oedema

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000888965

Acronym

DIMECAT

Enrollment

100

Registered

2011-08-19

Start date

2012-02-29

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will compare two medications (Avastin (bevacizumab) and Triesence (Triamcinolone) given at the time of cataract surgery for patients with, or at high risk of developing, diabetic macular oedema. Patients will be seen monthly and outcomes include visual acuity, centra macular thickenss, time to retreatment and assesment of adverse events.

Interventions

Arm 1: Avastin (bevacizumab) 1.25mg intravitreal injection, single dose administered immediately following cataract surgery

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

Clinically significant macular oedema involving the fovea of the study eye at baseline OR which has occured within 24 months of study entry OR microaneurysms within the foveal avascular zone which are not amenable to treatment with laser Cataract in the study eye which requires extraction in the opinion of the investigator

Exclusion criteria

Glaucoma with visual field defects or uncontrolled glaucoma Past history of intraocular pressure rise >35mmHg following steroid treatment Significant macular ischemia Visual acuity of <6/60 in the fellow eye Known allergies to the study medications Systemic treatment with steroids >5mg prednisolone (or equivalent) daily Intercurrent severe systemic disease or ocular infection Women of childbearing potential not using adequate contraception or women who are breastfeeding Intravitreal triamcinolone within 10 weeks of study entry Intravitreal Avastin within 3 weeks of study entry Argon laser photocoagulation within 3 months prior to study entry

Outcome results