Phase 2
Completed N=30
Use of Ranibizumab With Mitomycin C During Trabeculectomy
Source: ClinicalTrials.gov NCT00661583 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Assessment of Ocular Adverse Events — 0; 0; 0 Number of Reported Adverse Events
Summary
The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Ocular Adverse Events |
0; 0; 0 | — |
| SECONDARY Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months. |
100; 100; 100 | — |
| SECONDARY Mean Change in in Intraocular Pressure. |
-6.40; -6.40; -8.35; -6.60; -4.90; -8.00 | — |
| SECONDARY Mean Change in Visual Acuity |
-0.01; 0.01; 0.13; -0.05; 0.05; 0.13 | — |
Eligibility Criteria
Inclusion Criteria
- glaucoma
- undergoing trabeculectomy
- 21 years of age or older
Exclusion Criteria
- pregnancy or lactation
- any condition the investigator believes would impose a significant hazard to the patient if investigational therapy were initiated
- history of ocular surface disease
- cataract surgery in the past 6 months
- history of active inflammatory, infectious or idiopathic keratitis
Data sourced from ClinicalTrials.gov (NCT00661583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.