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Fluorouracil Filtering Surgery Study (FFSS)

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
5-Fluorouracil
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 1999
    Last Updated
    September 16, 2009
    Sponsor
    National Eye Institute (NEI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000122
    Brief Title
    Fluorouracil Filtering Surgery Study (FFSS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1985 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 1988 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Eye Institute (NEI)

    4. Oversight

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    5-Fluorouracil

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    2688428
    Citation
    Fluorouracil Filtering Surgery Study one-year follow-up. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1989 Dec 15;108(6):625-35. doi: 10.1016/0002-9394(89)90853-2.
    Results Reference
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    PubMed Identifier
    1575223
    Citation
    Risk factors for suprachoroidal hemorrhage after filtering surgery. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1992 May 15;113(5):501-7. doi: 10.1016/s0002-9394(14)74720-8.
    Results Reference
    background
    PubMed Identifier
    8420383
    Citation
    Three-year follow-up of the Fluorouracil Filtering Surgery Study. Am J Ophthalmol. 1993 Jan;115(1):82-92. doi: 10.1016/s0002-9394(14)73529-9.
    Results Reference
    background
    PubMed Identifier
    8604728
    Citation
    Five-year follow-up of the Fluorouracil Filtering Surgery Study. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1996 Apr;121(4):349-66. doi: 10.1016/s0002-9394(14)70431-3.
    Results Reference
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    Links:
    URL
    http://www.nei.nih.gov/news/pressreleases/ffsspressrelease.asp
    Description
    NEI Press Release-Fluorouracil Improves Glaucoma Surgery Outcome

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    Fluorouracil Filtering Surgery Study (FFSS)

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