Glaucoma
Conditions
Keywords
glaucoma, glucoma filtering surgery, ranibizumab, mitomycin C, patients requiring first time glaucoma filtering surgery
Brief summary
Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include late bleb leaks, hypotony and infection.
Detailed description
This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab 0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the surgery. No mitomycin C will be applied. Post operative follow-up will consist of a minimum of 6 visits during a one year period.
Interventions
DRUGRanibizumab
Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
DRUGMitomycin (MMC)
Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
Sponsors
Genentech, Inc.
Novartis Pharmaceuticals
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 yrs or older * patients requiring first time glaucoma filtering surgery * phakic or pseudophakic * must provide written informed consent and comply with study assignments
Exclusion criteria
* Pregnant, lactation or premenopausal women not using adequate contraception. * Previous glaucoma surgery, tube shunt surgery, pars plana vitrectomy, scleral buckle, penetrating keratoplasty. * Abnormality preventing reliable applanation tonometry in each eye. * Current infection or inflammation in either eye. * Enrolled in another investigational study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 12 months | Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Requirement for Glaucoma Medication | 1 day, 2 wks, 1, 3, 6 and 12 months | Mean number of glaucoma medications used by each participant over the course of one year post-operatively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment 1 (Ranibizumab 0.5mg) Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.
Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery | 12 |
| Treatment 2 (Mitomycin C 0.4 mg/ml) Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.
Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Treatment 1 (Ranibizumab 0.5mg) | Treatment 2 (Mitomycin C 0.4 mg/ml) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Continuous | 67 Years | 68.5 Years | 67.75 Years |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 12 / 12 | 2 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Adverse Events
Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1 (Ranibizumab 0.5mg) | Adverse Events | 100 percentage of participants |
| Treatment 2 (Mitomycin C 0.4 mg/ml) | Adverse Events | 16.67 percentage of participants |
Secondary
Post-Operative Requirement for Glaucoma Medication
Mean number of glaucoma medications used by each participant over the course of one year post-operatively.
Time frame: 1 day, 2 wks, 1, 3, 6 and 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment 1 (Ranibizumab 0.5mg) | Post-Operative Requirement for Glaucoma Medication | 12 months | 0.15 number of glaucoma medications used |
| Treatment 1 (Ranibizumab 0.5mg) | Post-Operative Requirement for Glaucoma Medication | 1 Day | 0.01 number of glaucoma medications used |
| Treatment 1 (Ranibizumab 0.5mg) | Post-Operative Requirement for Glaucoma Medication | 2 wks | 0.0 number of glaucoma medications used |
| Treatment 1 (Ranibizumab 0.5mg) | Post-Operative Requirement for Glaucoma Medication | 1 month | 0.13 number of glaucoma medications used |
| Treatment 1 (Ranibizumab 0.5mg) | Post-Operative Requirement for Glaucoma Medication | 3 months | 0.66 number of glaucoma medications used |
| Treatment 1 (Ranibizumab 0.5mg) | Post-Operative Requirement for Glaucoma Medication | 6 months | 0.34 number of glaucoma medications used |
| Treatment 2 (Mitomycin C 0.4 mg/ml) | Post-Operative Requirement for Glaucoma Medication | 3 months | 0.08 number of glaucoma medications used |
| Treatment 2 (Mitomycin C 0.4 mg/ml) | Post-Operative Requirement for Glaucoma Medication | 12 months | 0.06 number of glaucoma medications used |
| Treatment 2 (Mitomycin C 0.4 mg/ml) | Post-Operative Requirement for Glaucoma Medication | 1 month | 0.01 number of glaucoma medications used |
| Treatment 2 (Mitomycin C 0.4 mg/ml) | Post-Operative Requirement for Glaucoma Medication | 1 Day | 0.0 number of glaucoma medications used |
| Treatment 2 (Mitomycin C 0.4 mg/ml) | Post-Operative Requirement for Glaucoma Medication | 6 months | 0.06 number of glaucoma medications used |
| Treatment 2 (Mitomycin C 0.4 mg/ml) | Post-Operative Requirement for Glaucoma Medication | 2 wks | 0.01 number of glaucoma medications used |