Phase 4
N=59
Use of Bevacizumab in Trabeculectomy Surgery
Glaucoma · Optic Neuropathy · Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01166594 ↗Enrolled (actual)
59
Serious AEs
53.2%
Results posted
Aug 2023
Primary outcome: Primary: Intraocular Pressure — 13.9; 13.2 mm Hg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bevacizumab (Drug); Control (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sunnybrook Health Sciences Centre
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure |
13.9; 13.2 | <0.05 sig |
| SECONDARY Improved Bleb Appearance |
14; 12 | — |
| SECONDARY The Number of Participants Who Received 5-Fluorouracil (5-FU) Injections |
13; 7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age more than 18 years old
- Patients with glaucoma that is inadequately controlled on maximal tolerated medical therapy and scheduled for trabeculectomy surgery (with/without combined cataract extraction)
- Decision makers fluent in English
- Decision makers able to understand and read consent form
Exclusion Criteria
- Patients with active intraocular inflammation/uveitis or neovascular glaucoma
- History of previous trabeculectomy surgery or prior retinal detachment with scleral buckle placement in the surgical eye
- Aphakia in surgical eye
- Pregnant and nursing women
- Unable to fulfill inclusion criteria
- Refusal of consent
Data sourced from ClinicalTrials.gov (NCT01166594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.