Phase 3
Completed N=24
Lucentis Versus Mitomycin C During Glaucoma Surgery
Source: ClinicalTrials.gov NCT00626782 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Adverse Events — 100; 16.67 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
100; 16.67 | — |
| SECONDARY Post-Operative Requirement for Glaucoma Medication |
0.01; 0.0; 0.0; 0.01; 0.13; 0.01 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00626782). 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.