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Lucentis Versus Mitomycin C During Glaucoma Surgery - NCT00626782-19107(Clinical Trial 206609)



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City:  Philadelphia
State:  
PA
Zip Code: 19107
Conditions: Glaucoma
Purpose: 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.
Study summary: This is an open-label, single center trial with two arms for patients who will undergo 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 over a one year period.
Criteria: 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.
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Data Source: ClinicalTrials.gov
Date Processed: June 22, 2010
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