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Trial NCT00000122

Resource URI: http://static.linkedct.org/resource/trials/NCT00000122
PropertyValue
linkedct:brief_title Fluorouracil Filtering Surgery Study (FFSS)
linkedct:condition <http://static.linkedct.org/resource/condition/5287>
linkedct:criteria Men and women with uncontrolled intraocular pressure greater than 21 mm Hg in one or both eyes despite maximal tolerated therapy and who were aphakic or had undergone previous filtering surgery were eligible to participate.
linkedct:description Filtering surgery adequately lowers intraocular pressure in most glaucoma patients. However, the prognosis is less favorable for aphakic patients with glaucoma or glaucoma in phakic eyes following unsuccessful filtering operations. Failure of filtering surgery is usually attributed to the proliferation of fibroblasts at the filtering site. The use of 5-FU, an antimetabolite, has been shown to inhibit the proliferation of fibroblasts in tissue culture, and in preliminary studies it has increased the success of filtering surgery in a nonhuman primate model. The Fluorouracil Filtering Surgery Study (FFSS) was a randomized, controlled clinical trial comparing the success rate of standard glaucoma filtering surgery to the success rate of standard surgery with adjunctive 5-FU treatment. Another element of this study was to evaluate the frequency and severity of possible adverse effects related to 5-FU injections. Detailed preoperative and postoperative examinations of the cornea, lens, and retina were performed. Systemic toxicity was assessed by preoperative and postoperative hematologic studies. After the investigators performed the filtering surgery and determined that the new outlet channel was working, patients were randomized to receive either 5-FU injections or standard postsurgical care without 5-FU. The patients treated with 5-FU received subconjunctival injections of 5 mg of 5-FU twice daily on postoperative days 1 through 7 and once daily on postoperative days 8 through 14. There were 213 patients recruited into the study, 162 with previous cataract extraction and 51 with previous filtering surgery. All patients were examined at 1 month, 3 months, 6 months, 1 year, 18 months, and 2 years postoperatively and at yearly intervals thereafter until 5 years postoperatively. Possible concomitant risks of 5-FU treatment, such as toxic effects to the cornea, lens, or retina, were monitored.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age N/A
linkedct:end_date June 1988
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 23, 1999
linkedct:id NCT00000122
rdfs:label Trial NCT00000122
linkedct:lastchanged_date September 16, 2009
linkedct:lead_sponsor_agency National Eye Institute (NEI)
linkedct:nct_id NCT00000122
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NEI-21
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000122>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/25921>
linkedct:reference <http://static.linkedct.org/resource/reference/39613>
linkedct:reference <http://static.linkedct.org/resource/reference/48755>
linkedct:reference <http://static.linkedct.org/resource/reference/49624>
linkedct:source National Eye Institute (NEI)
linkedct:start_date September 1985
linkedct:study_design Treatment, Randomized, Double-Blind
linkedct:study_type Interventional
linkedct:summary To determine whether postoperative subconjunctival injections of 5-fluorouracil (5-FU) increase the success rate of filtering surgery in patients at high risk for failure after standard glaucoma filtering surgery.
rdf:type linkedct:trials
linkedct:verification_date September 2009