Trial Outcomes & Findings for Use of Bevacizumab in Trabeculectomy Surgery (NCT NCT01166594)

NCT ID: NCT01166594

Last Updated: 2023-08-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 59 participants
• Primary outcome timeframe: One year
• Results posted on: 2023-08-21

Participant Flow

Participant milestones

Measure	Bevacizumab Tested Drug Bevacizumab: Intrableb injection - 30 patients	Control Control - BSS Control: intrableb BSS injection - 29 patients
Overall Study STARTED	30	29
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Bevacizumab in Trabeculectomy Surgery

Baseline characteristics by cohort

Measure	Bevacizumab n=23 Participants Tested Drug Bevacizumab: Intrableb injection	Control n=24 Participants Control - BSS Control: intrableb BSS injection	Total n=47 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 10.8 • n=5 Participants	61.3 years STANDARD_DEVIATION 10.4 • n=7 Participants	62.5 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Canada	23 participants n=5 Participants	24 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: One year

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

Outcome measures

Measure	Bevacizumab n=23 Participants Tested Drug Bevacizumab: Intrableb injection - 30 patients	Control n=24 Participants Control - BSS Control: intrableb BSS injection - 29 patients
Intraocular Pressure	13.9 mm Hg Standard Deviation 4.5	13.2 mm Hg Standard Deviation 5.1

SECONDARY outcome

Timeframe: One year

Improved bleb appearance was formally graded according to the Indiana bleb-grading scheme at each visit.

The scheme has 4 sections: height of the bleb (H) with a range of H0 (flat bleb) to H4 (high bleb), horizontal extent of the bleb with a range of E0 (less than 1 clock hour) to E3 (more than 4 clock hours), vascularity of the bleb with a range of V0 (avascular) to V4 (extensive vascularity), and siedel test ranging from S0 (no leak) to S2 (streaming leak within 5 seconds).

Each section was individually scored. Ophthalmic photographs of the surgical site were taken with patient consent. The photographs only included a small portion of the eye and the patient cannot be identified by them.

Outcome measures

Measure	Bevacizumab n=23 Participants Tested Drug Bevacizumab: Intrableb injection - 30 patients	Control n=24 Participants Control - BSS Control: intrableb BSS injection - 29 patients
Improved Bleb Appearance	14 Participants	12 Participants

SECONDARY outcome

Timeframe: One year

The number of participants who needed 5-FU injections during the first post-operative year for additional would modulation will be compared between the two groups.

Outcome measures

Measure	Bevacizumab n=23 Participants Tested Drug Bevacizumab: Intrableb injection - 30 patients	Control n=24 Participants Control - BSS Control: intrableb BSS injection - 29 patients
The Number of Participants Who Received 5-Fluorouracil (5-FU) Injections	13 Participants	7 Participants

Adverse Events

Bevacizumab

Serious events: 14 serious events

Other events: 6 other events

Deaths: 0 deaths

Control

Serious events: 11 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bevacizumab n=23 participants at risk Tested Drug Bevacizumab: Intrableb injection - 30 patients	Control n=24 participants at risk Control - BSS Control: intrableb BSS injection - 29 patients
Eye disorders Bleb leak	34.8% 8/23 • Number of events 8	29.2% 7/24 • Number of events 7
Eye disorders Hypotony	60.9% 14/23 • Number of events 14	45.8% 11/24 • Number of events 11
Eye disorders Choroidal Detachment	26.1% 6/23 • Number of events 6	16.7% 4/24 • Number of events 4

Other adverse events

Measure	Bevacizumab n=23 participants at risk Tested Drug Bevacizumab: Intrableb injection - 30 patients	Control n=24 participants at risk Control - BSS Control: intrableb BSS injection - 29 patients
Eye disorders Other	26.1% 6/23	29.2% 7/24

Additional Information

Dr Catherine Birt

Sunnybrook Health Sciences Centre

Phone: 416 480-5882

Email: catherine.birt@sunnybrook.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place