CompletedPhase 1ACTRN12607000318482

Avastin in the prevention of postoperative scarring after glaucoma filtration surgery.

Does Avastin provide an additional antiscarring benefit to patients undergoing a trabeculectomy to improve the function of their filtration bleb and thus better maintain their target intraocular pressure postoperatively?

Sponsor

Monash Universtity

Enrollment

50 participants

Start Date

Mar 30, 2007

Study Type

Interventional

Conditions

Glaucoma, uncontrolled intraocular eye pressure, trabeculectomy, postoperative intervention, subconjunctival delievery.

Summary

Main purpose of this study is to identify whether a single injection of Avastin, in addition to the current antiscarring treatment 5 FU, improves the outcome from trabeculectomy surgery.

Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 80 Yearss

Inclusion Criteria1

Patients within 4 weeks of their first trabeculectomy who are deemed on clinical grounds to require the standard antiscarring treatment (5 FU).

Exclusion Criteria1

Active or recent bleb leak, known hypersensitivity to 5 FU, only eye, active bleb inflammation, inability to complete the informed consent, uncontrolled systemic condition within the previous month.

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Interventions

Particpants will be invited into the study if they suit the eligibility criteria. Written informed consent will be obtained from all participants. Participants will be randomised into a treatment gr

Particpants will be invited into the study if they suit the eligibility criteria. Written informed consent will be obtained from all participants. Participants will be randomised into a treatment group or a control group. Patients are randomised by opening a masked envelope that contains a randomisation group category generated by a computer based sequence table. All Participants will have the standard antiscarring treatment (5 FU) and if the participant is randomised into the treatment group, will then receive the additional study drug (Avastin). A thorough eye examination and photos of the surgical/treatment site will be performed at all follow up visits. Study Drug Dose = a single 1mg dose. Mode of Administration of Study Drug = dose is administered according to the established clinical hospital protocol for antifibrotic agents given via a subconjunctival injection into the filtration bleb. Study Drug Duration = A single injection of the study drug is given with an expected half life of up to 20 days.

Locations(1)

Australia

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ACTRN12607000318482