Glaucoma
Conditions
Keywords
Glaucoma,Ahmed Valve
Brief summary
To determine whether ranibizumab therapy before and after tube insertion for glaucoma surgeries can maintain the patency of the tube and prevent scar formation, and increase the chances for a successful procedure compared to observation.
Detailed description
This is a randomized, open-label, Phase I/II study of intravitreally administered ranibizumab for the treatment of tube patency in glaucoma patients. Thirty (30) patients with severe glaucoma requiring tubes will be randomized (2:1) to either ranibizumab or observation. Consented, enrolled subjects assigned to the treatment group will receive open-label intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections Sham intravitreal injections for the observation group will NOT be performed. Study periods: Study start date: May 1st, 2007 (estimated) Enrollment period: 6-8 months (estimated) Follow-up period: 6 months Study end Date: December 1st, 2010 (estimated)
Interventions
DRUGRanibizumab
intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections
Sponsors
Genentech, Inc.
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ability to provide written informed consent and comply with study assessment for the full duration of the study. 2. age ≥ 21 3. diagnosis of glaucoma and determined to be candidate for therapy with tube insertion.
Exclusion criteria
1. pregnant or lactating females 2. Persons on oral contraceptives and women of child-bearing age 3. prior enrollment in the study 4. any conditions the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated 5. participation in another simultaneous medical investigation or trial 6. history of active inflammatory, infectious, or idiopathic keratitis precluding view of anterior segment structures 7. previous injections of ranibizumab in either eye. 8. Persons on Plavix (clopidogrel bisulfate) and coumadin 9. Persons with uncontrolled high blood pressure 10. Persons with renal or liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tube Success at 6 Months | 6 months | Criteria for success at 6 months postoperatively was intraocular pressure (IOP) \< 18mmHg without the necessity for adjunctive medication for pressure or IOP \< 15mmHg with \<=1 adjunctive medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Significant Ocular Adverse Events | 6 months | Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the University of California, San Francisco (UCSF) Glaucoma Service
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery | 6 |
| Usual Care Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Ranibizumab | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 6 participants | 5 participants | 11 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
Tube Success at 6 Months
Criteria for success at 6 months postoperatively was intraocular pressure (IOP) \< 18mmHg without the necessity for adjunctive medication for pressure or IOP \< 15mmHg with \<=1 adjunctive medication.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab | Tube Success at 6 Months | 83 percentage of participants |
| Usual Care | Tube Success at 6 Months | 40 percentage of participants |
Secondary
Significant Ocular Adverse Events
Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab | Significant Ocular Adverse Events | 0 participants |
| Usual Care | Significant Ocular Adverse Events | 0 participants |