Lucentis Versus Mitomycin C During Glaucoma Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-04-30

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.

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 posteriorly to the limbus as an antifibrotic agent.

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery

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.

Group Type ACTIVE_COMPARATOR

Mitomycin (MMC)

Intervention Type DRUG

Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.

Interventions

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Ranibizumab

Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery

Intervention Type DRUG

Mitomycin (MMC)

Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.

Intervention Type DRUG

Other Intervention Names

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Lucentis MMC C 0.4 mg/ml

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No