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

Phase 2

Recruiting

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

• Registration Number: ACTRN12611000888965
• Lead Sponsor: Royal Victorian Eye and Ear Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity[1 month, 6 months and 12 months post cataract surgery ]

Secondary Outcome Measures

Name	Time	Method
Central macular thickness measured on Optical Coherence tomography[1 month, 6 months and 12 months post cataract surgery ];Comparison of time to retreatment between two groups (where treatment includes additional laser or intravitreal injections)[Up to twelve months ];Rate and severity of adverse reactions, for example, intraocular pressure will be monitored and compared between groups. An IOP elevation will be consdiered mild if it is between 22-29mmHg, moderate if it is 30mmHg or above and severe if it requires surgical intervention. Rates of endophthalmitis (if any) will be compared between groups.<br>Details on all adverse events which the patients experience during the study will be recorded including its duration, the severity grade (mild, moderate, severe), its relationship to the study drug (suspected / not suspected) and the action(s) taken.[Each study visit (week 1, months 1,2,3,4,5,6,7,8,9,10,11,12)]