NCT00000122

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1985

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1985

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1988

Completed
11.3 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

First QC Date

September 23, 1999

Last Update Submit

September 16, 2009

Conditions

Glaucoma

Interventions

5-FluorouracilDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 2688428BACKGROUND

  • 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.

    PMID: 1575223BACKGROUND

  • 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.

    PMID: 8420383BACKGROUND

  • 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.

    PMID: 8604728BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

September 1, 1985

Study Completion

June 1, 1988

Last Updated

September 17, 2009

Record last verified: 2009-09