NCT00626782

Lucentis Versus Mitomycin C During Glaucoma Surgery

Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, single center trial with two arms for patients who underwent 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 during a one year period.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	Ranibizumab	Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
DRUG	Mitomycin (MMC)	Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-02-29
• Last updated: 2018-03-22
• Results posted: 2015-03-13

Locations

1 site across 1 country: United States