Project: Research project

Project Details


The first goal of this two-part application is to determine the long-term,
five year safety and efficacy of subconjunctivally injected 5-FU through
the continued follow-up of 213 patients in the Fluorouracil Filtering
Surgery Study Clinical Trial (FFSS). The FFSS a multicenter randomized
clinical trial, began in September 1985 to determine if postoperative
subconjunctival injections of 5-fluorouracil (5-FU) would increase the
success rate of glaucoma filtering surgery in eyes with poor prognoses.
Patients with medically uncontrolled glaucoma after previous cataract
extraction or unsuccessful filtering surgery, or both, were randomized to
undergo trabeculectomy alone (standard treatment) or trabeculectomy with
adjunctive 5-FU injections. Postoperative success and failure rates were
determined by reoperation rates and by defined intraocular pressure (IOP)
levels. Possible risks of 5-FU, such as corneal, lenticular, retinal, and
hematologic toxicities were monitored. The Safety and Data Monitoring
Committee recommended stopping recruitment in June 1988 when the success
rate after one year follow-up in the 5-FU group was approximately 80% vs
60% in the standard treatment group (p=.0004). The five year follow-up of
these 213 patients will be sufficient to determine the long-term status of
visual function, as measured by the stability of visual field and acuity,
and the attendant risks of treatment with 5-FU. Important information
regarding the long-term effect of IOP control in eyes with advanced
glaucoma will also be generated through the continued follow-up.

The second goal of this two-part application is to establish a FFSS-Patient
Registry to determine the efficacy and safety of a standardized low-dose 5-
FU dosage regimen: 5mg once daily on postoperative days 1-7, and 5mg three
times during days 8-14 in patients comparable to those in the FFSS-Clinical
Trial. This dose has been chosen to minimize corneal and conjunctival
epithelial toxicity. Currently most non-FFSS ophthalmologists are using a
variably reduced 5-FU dose that has not been tested in a controlled
fashion. The FFSS Patient Registry will establish the baseline efficacy
and side effects of low dose 5-FU for future comparison with newer
alternative surgical therapies. The clinical course will be determined by
standardized measurements of visual acuity, perimetry and IOP, and
assessment of the side effects using the same personnel and equipment as in
the FFSS Clinical Trial. A sample size of 100 patients in the FFSS Patient
Registry will provide results to be compared with the 105 patients who
received high dose 5-FU in the FFSS Clinical Trial generate sufficient data
regarding efficacy and toxicity.
Effective start/end date4/1/903/31/94


  • National Eye Institute
  • National Eye Institute
  • National Eye Institute


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