Lucentis Versus Mitomycin C During Glaucoma Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Ranibizumab
* Drug: Mitomycin (MMC)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Ranibizumab 0.5mg (0.05mL) injection<br>Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent. | Drug: Ranibizumab<br>* Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery<br>* Other names: Lucentis;|
| Active Comparator: B: Mitomycin C 0.4 mg/ml sponge<br>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 (MMC)<br>* Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.<br>* Other names: MMC C 0.4 mg/ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Operative Requirement for Glaucoma Medication | Mean number of glaucoma medications used by each participant over the course of one year post-operatively. | 1 day, 2 wks, 1, 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, glucoma filtering surgery, ranibizumab, mitomycin C, patients requiring first time glaucoma filtering surgery