Lucentis Versus Mitomycin C During Glaucoma Surgery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery|
- Adverse Events [ Time Frame: 1 day, 2 wks, 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]Incidence and severity of ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs.
- Efficacy [ Time Frame: 1 day, 2 wks, 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]Mean change in intraocular pressure, number of glaucoma medications, bleb appearance based on the Indiana Bleb Appearance grading scale.
|Study Start Date:||January 2008|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: A: Ranibizumab 0.5mg (0.05mL) injection
Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriiorly to the limbus as an antifibrotic agent.
Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
Other Name: Lucentis
Active Comparator: B: Mitomycin C 0.4 mg/ml sponge
Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. This is the typical method used as an antifibrotic agent.
Drug: Mitomycin 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.
Other Name: MMC
This is an open-label, single center trial with two arms for patients who will undergo 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 over a one year period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626782
|United States, Pennsylvania|
|Wills Eye Hospital, Glaucoma Service|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Michael J Pro, MD||Wills Eye Institute|