Trial Outcomes & Findings for Use of Ranibizumab With Mitomycin C During Trabeculectomy (NCT NCT00661583)
NCT ID: NCT00661583
Last Updated: 2016-10-13
Results Overview
To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2016-10-13
Participant Flow
Participant milestones
| Measure |
Ranibizumab Alone
Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
|
Ranibizumab and MMC
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
|
MMC Alone
MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Ranibizumab With Mitomycin C During Trabeculectomy
Baseline characteristics by cohort
| Measure |
Ranibizumab Alone
n=10 Participants
Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
|
Ranibizumab and MMC
n=10 Participants
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
|
MMC Alone
n=10 Participants
MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
10 participants
n=27 Participants
|
30 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTo assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months
Outcome measures
| Measure |
Ranibizumab Alone
n=10 Participants
Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
|
Ranibizumab and MMC
n=10 Participants
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
|
MMC Alone
n=10 Participants
MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
|
|---|---|---|---|
|
Assessment of Ocular Adverse Events
|
0 Number of Reported Adverse Events
|
0 Number of Reported Adverse Events
|
0 Number of Reported Adverse Events
|
SECONDARY outcome
Timeframe: 6 monthsTo determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications)
Outcome measures
| Measure |
Ranibizumab Alone
n=10 Participants
Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
|
Ranibizumab and MMC
n=10 Participants
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
|
MMC Alone
n=10 Participants
MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
|
|---|---|---|---|
|
Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.
|
100 percentage of subjects
|
100 percentage of subjects
|
100 percentage of subjects
|
SECONDARY outcome
Timeframe: 6 monthsMean change in in intraocular pressure at 3 months and at 6 months
Outcome measures
| Measure |
Ranibizumab Alone
n=10 Participants
Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
|
Ranibizumab and MMC
n=10 Participants
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
|
MMC Alone
n=10 Participants
MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
|
|---|---|---|---|
|
Mean Change in in Intraocular Pressure.
month 3 minus baseline
|
-6.40 mmHg
Interval -26.0 to 2.0
|
-6.40 mmHg
Interval -15.0 to 0.0
|
-8.35 mmHg
Interval -26.0 to 0.0
|
|
Mean Change in in Intraocular Pressure.
month 6 minus baseline
|
-6.60 mmHg
Interval -32.0 to -1.0
|
-4.90 mmHg
Interval -16.0 to 1.0
|
-8.00 mmHg
Interval -24.0 to -2.0
|
SECONDARY outcome
Timeframe: 6 monthsMean change in visual acuity in logMAR.
Outcome measures
| Measure |
Ranibizumab Alone
n=10 Participants
Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
|
Ranibizumab and MMC
n=10 Participants
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
|
MMC Alone
n=10 Participants
MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
|
|---|---|---|---|
|
Mean Change in Visual Acuity
Month 3 minus baseline
|
-0.01 logMAR
Interval -0.22 to 0.12
|
0.01 logMAR
Interval -0.12 to 0.18
|
0.13 logMAR
Interval -0.04 to 0.48
|
|
Mean Change in Visual Acuity
Month 6 minus baseline
|
-0.05 logMAR
Interval -0.22 to 0.13
|
0.05 logMAR
Interval -0.14 to 0.18
|
0.13 logMAR
Interval -0.05 to 0.32
|
Adverse Events
Ranibizumab Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ranibizumab and MMC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MMC Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place