Lucentis Versus Mitomycin C During Glaucoma Surgery

Phase 2

Completed

• Conditions: Glaucoma
• Interventions: Drug: Mitomycin (MMC); Drug: Ranibizumab

• Registration Number: NCT00626782
• Lead Sponsor: Wills Eye

Brief 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-29
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2015-02-11
• Results First Submitted QC: 2015-03-12
• Results First Posted: 2015-03-13
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-23
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B: Mitomycin C 0.4 mg/ml sponge	Mitomycin (MMC)	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.
A: Ranibizumab 0.5mg (0.05mL) injection	Ranibizumab	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.

Primary Outcome Measures

Name	Time	Method
Adverse Events	12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wills Eye Hospital, Glaucoma Service; 🇺🇸 Philadelphia, Pennsylvania, United States