Use of Bevacizumab in Trabeculectomy Surgery

Status Completed

Clinical Trial 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.

Clinical Trial Description

The usual treatment is to not have an injection of Bevacizumab on the third through fifth day after trabeculectomy surgery. Topical anaesthetic drops to numb the eye will be given, prior to being given the tested medicine. Once the eye has been anaesthetized, the medication will be injected into the potential space created during the glaucoma surgery, also called a bleb, using a standard small syringe. The patient will receive an injection of either 1.25mg (0.05ml) of Bevacizumab or Balanced Salt Solution (BSS) into the trabeculectomy bleb that had been created in the surgery. Participants will be randomly (by chance) placed in one of the 2 study groups. There will be a 50% chance of being placed in either group. There will be 60 people who will participate in this study at 2 centres throughout the Toronto region. The length of this study for participants is 12 months, and the entire study is expected to take about 18 months to complete. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01166594
Study type	Interventional
Source	Sunnybrook Health Sciences Centre
Contact
Status	Completed
Phase	Phase 4
Start date	June 2010
Completion date	December 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06000865` - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE	N/A
Recruiting	`NCT06278597` - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device	N/A
Active, not recruiting	`NCT04271709` - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)	N/A
Recruiting	`NCT03274024` - The Asia Primary Tube Versus Trab (TVT) Study	N/A
Completed	`NCT04552964` - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma	N/A
Recruiting	`NCT01957267` - Functional and Structural Imaging for Glaucoma
Active, not recruiting	`NCT04624698` - iStent Inject New Enrollment Post-Approval Study	N/A
Completed	`NCT04020705` - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma	N/A
Completed	`NCT03150160` - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma	Phase 4
Not yet recruiting	`NCT05581498` - Glaucoma Exercise as Medicine Study (GEMS).	N/A
Recruiting	`NCT02921568` - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes	N/A
Active, not recruiting	`NCT02901730` - Clinical Study of LPI With Different Laser Wavelengths	N/A
Completed	`NCT02955849` - A Trial of China Laser and Surgery Study Glaucoma in Rural China	Early Phase 1
Recruiting	`NCT02554214` - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device	N/A
Recruiting	`NCT02471105` - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml	Phase 4
Active, not recruiting	`NCT02390284` - Stop Retinal Ganglion Cell Dysfunction Study	Phase 3
Completed	`NCT02653963` - Triamcinolone for Ahmed Glaucoma Valve	N/A
Completed	`NCT02628223` - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma	N/A
Completed	`NCT02520674` - Glaucoma Screening With Smartphone Ophthalmology	N/A
Completed	`NCT02246764` - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.