Use of Bevacizumab in Trabeculectomy Surgery

Sponsor
Sunnybrook Health Sciences Centre
Study ID
NCT01166594
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Intrableb injection
  • Control — DRUG
    intrableb BSS injection

Study Details

When a patient with glaucoma who has a pressure that is too high and causing damage to their vision, despite receiving the maximum amount of medication that can be tolerated, the decision is made to have glaucoma surgery. Trabeculectomy is the most common form of glaucoma surgery used to treat open angle glaucoma. During trabeculectomy, an opening is created in the eye and partially covered with a flap of tissue. This new opening allows fluid to drain out of the eye bypassing the clogged drainage channels that are malfunctioning in patients with glaucoma. Studies have found that trabeculectomy significantly reduces vision loss and lowers eye pressure. However, many people need another trabeculectomy or other glaucoma surgery because the surgery may fail either early or much later because the body closes the drain created by the surgeon. The surgery is also less likely to work in patients with darker pigmentation, children who have congenital glaucoma, people with difficult to control glaucoma with new blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result, the investigators need to find ways to improve the longterm survival of trabeculectomy surgery in all patients.

Key Dates

First listed
Jul 21, 2010
Start date
Jun 30, 2010
Status verified
Oct 2022
Primary completion
Sep 30, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    Tested Drug
  • Placebo Comparator: Control
    Control - BSS

Primary Outcome Measure

Intraocular Pressure [ Time Frame: One year ]

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