Not Yet RecruitingPhase 3Phase 4ACTRN12614000375651

The Avastin in Trabeculectomy Study

A randomised double-blinded study to assess the ability for intravitreal bevacizumab to increase the proportion of glaucoma patients with intraocular pressure at or below target following glaucoma drainage surgery.


Sponsor

A/Prof John Landers

Enrollment

100 participants

Start Date

Jun 1, 2014

Study Type

Interventional

Conditions

Summary

Glaucoma is a progressive disease of the optic nerve, which if undiagnosed, can lead to blindness. Surgery is often reserved for very severe cases and as such, surgical success is imperative. Our project will address this by performing a randomised double blinded assessment of the adjunctive use of intraoperative intravitreal bevacizumab (Avastin), a currently available and widely used anti-VEGF drug, on post-operative glaucoma surgery success. If this intervention is successful, the outcomes could undoubtedly influence future surgical management.


Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 90 Yearss

Inclusion Criteria1

  • Those requiring a trabeculectomy or a phaco-trabeculectomy based on the judgement of the treating surgeon

Exclusion Criteria1

  • Anterior segment dysgenesis, irido-corneal-endothelial syndrome, proliferative diabetic retinopathy, congenital or juvenile-onset glaucoma, traumatic glaucoma, rubeotic glaucoma, previous corneal graft surgery, previous vitrectomy surgery requiring silicone oil, any condition for which the patient is currently receiving intravitreal anti-VEGF medication. However, previous cataract or trabeculectomy surgery is not an exclusion.

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Interventions

A single intraoperative intravitreal injection of bevacizumab 1.25mg in 0.05ml

A single intraoperative intravitreal injection of bevacizumab 1.25mg in 0.05ml


Locations(2)

Flinders Medical Centre - Bedford Park

SA, Australia

Repatriation Hospital - Daw Park

SA, Australia

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ACTRN12614000375651


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