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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
Wills Eye Hospital, Glaucoma Service
Philadelphia, Pennsylvania, United States
Adverse Events
Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.
Time frame: 12 months
Post-Operative Requirement for Glaucoma Medication
Mean number of glaucoma medications used by each participant over the course of one year post-operatively.
Time frame: 1 day, 2 wks, 1, 3, 6 and 12 months
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