Fluorouracil Filtering Surgery Study (FFSS)



Sponsors


Source

National Eye Institute (NEI)

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.

Overall Status

Completed

Start Date

1985-09-01

Completion Date

1988-06-01

Primary Completion Date

N/A

Phase

Phase 3

Study Type

Interventional


Condition


Intervention

Intervention Type

Drug

Intervention Name



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.

Gender

All

Minimum Age

N/A

Maximum Age

N/A

Healthy Volunteers

No


Verification Date

2009-09-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Has Expanded Access

No

Intervention Browse

Mesh Term

Fluorouracil


Firstreceived Results Date

N/A

Reference

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.

PMID

2688428


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.

PMID

1575223


Citation

Three-year follow-up of the Fluorouracil Filtering Surgery Study. Am J Ophthalmol. 1993 Jan;115(1):82-92.

PMID

8420383


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.

PMID

8604728



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Primary Purpose

Treatment

Masking

Double


Study First Submitted

September 23, 1999

Study First Submitted Qc

September 23, 1999

Study First Posted

September 24, 1999

Last Update Submitted

September 16, 2009

Last Update Submitted Qc

September 16, 2009

Last Update Posted

September 17, 2009


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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