Use of Bevacizumab in Trabeculectomy Surgery

NCT01166594 | Completed Phase 4 Results

• 1 other identifier: 136783
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma; Optic Neuropathy; Fibrosis

Keywords

Glaucoma; Elevated Intraocular Pressure (IOP); Optic Neuropathy; Bleb Failure; Avastin (Bevacizumab)

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

  Intraocular pressure comparison between the two groups at one year following surgery. A window of ±14 days was allowed for the one-year visit

  One year

Secondary Outcomes (2)

• Improved Bleb Appearance

  One year

• The Number of Participants Who Received 5-Fluorouracil (5-FU) Injections

  One year

Study Arms (2)

Bevacizumab

EXPERIMENTAL

Tested Drug

Drug: Bevacizumab

Control

PLACEBO COMPARATOR

Control - BSS

Drug: Control

Interventions

Bevacizumab DRUG

Intrableb injection

Also known as: Avastin

Bevacizumab

Control DRUG

intrableb BSS injection

Also known as: Saline

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Refusal of consent

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Glaucoma Research Society of Canada: collaborator

Study Sites (1)

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Glaucoma; Optic Nerve Diseases; Fibrosis; Ocular Hypertension

Interventions

Bevacizumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Eye Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr Catherine Birt
• Organization: Sunnybrook Health Sciences Centre

catherine.birt@sunnybrook.ca

416 480-5882

Study Officials

• Catherine Birt, MD, FRCSC

  Sunnybrook Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2022-10

Locations

CA (1)