Glaucoma
Conditions
Keywords
failing blebs, failing express shunt, avastin, bevacizumab, glaucoma, prior trabeculectomy, Express shunt placed under a scleral flap, subsequent filtration failure
Brief summary
The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.
Detailed description
To investigate the efficacy of needle bleb revisions with mitomycin C with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.
Interventions
DRUGbevacizumab
1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure
0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure
Sponsors
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* require glaucoma bleb needle revision with Mitomycin-C
Exclusion criteria
* pregnant, nursing, or not using adequate contraception * other glaucoma eye surgery involving tube shunts * prior retinal detachments surgery with scleral buckle * infection, inflammation, or any abnormality preventing eye pressure measurement * enrolled in another investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) | 6 months | mmHg (millimeters of mercury) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Success | 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. |
Countries
United States
Participant flow
Recruitment details
Eligible patients were recruited between February 2009 and July 2011 from the Glaucoma Service located at Wills Eye Hospital in Philadelphia.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 29 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Treatment A (Bevacizumab) | Total | Treatment B (Balanced Salt Solution) |
|---|---|---|---|
| Age, Continuous | 64.6 years | 67.9 years | 71.2 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 27 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 29 Participants | 14 Participants |
| Region of Enrollment United States | 29 participants | 58 participants | 29 participants |
| Sex: Female, Male Female | 11 Participants | 23 Participants | 12 Participants |
| Sex: Female, Male Male | 18 Participants | 35 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 17 / 29 | 15 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Intraocular Pressure (IOP)
mmHg (millimeters of mercury)
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment A (Bevacizumab) | Intraocular Pressure (IOP) | 11.52 mmHg (millimeters of mercury) |
| Treatment B (Balanced Salt Solution) | Intraocular Pressure (IOP) | 12.83 mmHg (millimeters of mercury) |
Secondary
Number of Participants With Surgical Success
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A (Bevacizumab) | Number of Participants With Surgical Success | Complete success | 17 Participants |
| Treatment A (Bevacizumab) | Number of Participants With Surgical Success | Qualified success | 0 Participants |
| Treatment A (Bevacizumab) | Number of Participants With Surgical Success | Failure | 12 Participants |
| Treatment B (Balanced Salt Solution) | Number of Participants With Surgical Success | Complete success | 12 Participants |
| Treatment B (Balanced Salt Solution) | Number of Participants With Surgical Success | Qualified success | 2 Participants |
| Treatment B (Balanced Salt Solution) | Number of Participants With Surgical Success | Failure | 15 Participants |