Trial Outcomes & Findings for Does Adding Bevacizumab Therapy in Glaucoma Surgery Improve the Success of Needle Bleb Revisions? (NCT NCT00853073)

NCT ID: NCT00853073

Last Updated: 2018-07-09

Results Overview

mmHg (millimeters of mercury)

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 63 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-07-09

Participant Flow

Eligible patients were recruited between February 2009 and July 2011 from the Glaucoma Service located at Wills Eye Hospital in Philadelphia.

Participant milestones

Measure	Treatment A (Bevacizumab) patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	Treatment B (Balanced Salt Solution) patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Overall Study STARTED	32	31
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Treatment A (Bevacizumab) patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	Treatment B (Balanced Salt Solution) patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Does Adding Bevacizumab Therapy in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?

Baseline characteristics by cohort

Measure	Treatment A (Bevacizumab) n=29 Participants patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	Treatment B (Balanced Salt Solution) n=29 Participants patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	Total n=58 Participants Total of all reporting groups
Age, Continuous	64.6 years n=5 Participants	71.2 years n=7 Participants	67.9 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

mmHg (millimeters of mercury)

Outcome measures

Measure	Treatment A (Bevacizumab) n=29 Participants patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	Treatment B (Balanced Salt Solution) n=29 Participants patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Intraocular Pressure (IOP)	11.52 mmHg (millimeters of mercury) Interval 9.44 to 14.05	12.83 mmHg (millimeters of mercury) Interval 10.44 to 15.77

SECONDARY outcome

Timeframe: 6 months

Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery.

Outcome measures

Measure	Treatment A (Bevacizumab) n=29 Participants patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	Treatment B (Balanced Salt Solution) n=29 Participants patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Number of Participants With Surgical Success Complete success	17 Participants	12 Participants
Number of Participants With Surgical Success Qualified success	0 Participants	2 Participants
Number of Participants With Surgical Success Failure	12 Participants	15 Participants

Adverse Events

Treatment A (Bevacizumab)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Treatment B (Balanced Salt Solution)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment A (Bevacizumab) n=29 participants at risk patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	Treatment B (Balanced Salt Solution) n=29 participants at risk patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Eye disorders Hyphema	13.8% 4/29 • Number of events 4 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.	10.3% 3/29 • Number of events 3 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.
Eye disorders Shallow Anterior Chamber	24.1% 7/29 • Number of events 7 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.	17.2% 5/29 • Number of events 5 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.
Eye disorders Shallow Anterior Chamber necessitating injection of viscoelastic	3.4% 1/29 • Number of events 1 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.	3.4% 1/29 • Number of events 1 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.
Eye disorders Endothelial folds	13.8% 4/29 • Number of events 4 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.	13.8% 4/29 • Number of events 4 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.
Eye disorders Retinal/Choroidal folds	17.2% 5/29 • Number of events 5 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.	17.2% 5/29 • Number of events 5 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.
Eye disorders Choroidals	20.7% 6/29 • Number of events 6 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.	3.4% 1/29 • Number of events 1 At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.

Additional Information

Marlene R. Moster, MD

Wills Eye Hospital

Phone: 215-928-3123

Email: marlenemoster@gmail.com

Results disclosure agreements

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