Does Adding Bevacizumab Therapy in Glaucoma Surgery Improve the Success of Needle Bleb Revisions? (Avastin)

W

Wills Eye

Status and phase

Completed
Phase 3
Phase 2

Conditions

Glaucoma

Treatments

Other: balanced salt solution
Drug: bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00853073
08-867

Details and patient eligibility

About

The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.

Full description

To investigate the efficacy of needle bleb revisions with mitomycin C with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • require glaucoma bleb needle revision with Mitomycin-C

Exclusion criteria

  • pregnant, nursing, or not using adequate contraception
  • other glaucoma eye surgery involving tube shunts
  • prior retinal detachments surgery with scleral buckle
  • infection, inflammation, or any abnormality preventing eye pressure measurement
  • enrolled in another investigational study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups, including a placebo group

Bevacizumab
Active Comparator group
Description:
subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Treatment:
Drug: bevacizumab
balanced salt solution
Placebo Comparator group
Description:
patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Treatment:
Other: balanced salt solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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