Intraoperative 5-fluorouracil Augmentation of Trabeculectomy

NCT06745856 | Completed Phase 3 DMC

• 1 other identifier: G9330070
• Study Type: interventional
• Target: 368
• Locations: 0 countries
• Sites: N/A

Brief Summary

5-fluorouracil (5FU) is an antimetabolite that has been demonstrated to have beneficial effects when injected into the subconjunctival space after glaucoma surgery (trabeculectomy). The hypothesis of this study is that a similar beneficial effect can be achieved with a single intraoperative application of 5FU. This hypothesis is tested with a randomized control study.

Conditions

Glaucoma; Primary Open Angle Glaucoma

Keywords

glaucoma; trabeculectomy; intraocular pressure; randomized control study; antimetabolite; 5 fluorouracil

Outcome Measures

Primary Outcomes (1)

• Glaucoma control

  Raised Intra Ocular Pressure (IOP) of \>21 millimetres of mercury (mmHg) on two or more consecutive visits recorded at the end of a visit following any physical intervention. Visual field progression that met a modified criteria of the Collaborative Normal Tension Glaucoma Study (CNTGS). Optic disc cupping progression identified by the examining clinician and confirmed with stereo-photographic documentation of the optic nerve neuroretinal rim changes read by two masked examiners. If any of these outcome measures were reached, the patient was classified as a 'trial failure' and then treated further depending on the clinicians discretion.

  a minimum of 3 years follow up

Secondary Outcomes (1)

• long term safety of intraoperative 5FU

  a minimum of 3 years follow up

Study Arms (2)

5-fluorouracil

ACTIVE COMPARATOR

antimetabolite to prevent wound healing

Drug: 5-fluorouracil

placebo

PLACEBO COMPARATOR

Subconjunctival placebo.

Drug: placebo

Interventions

5-fluorouracil DRUG

Subconjunctival, peroperative, application of 50mg/ml concentration of 5-fluoruracil.

Also known as: 5 fluorouracil subconjunctival injection

5-fluorouracil

placebo DRUG

Subconjunctival, peroperative application of normal saline (NaCl 0.9%)

Also known as: sodium chloride solution (0.9%)"

placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A measured intraocular pressure \> or equal to 22 mm Hg on at least one visit before the time of listing for surgery and while on the current drop regime.
• The ability to complete a Humphrey 24-2 visual field test with \<20% false positives, \<33% false negatives and \<20% fixation losses, and the presence of 2 locations \> 5decibels (dB) less than normal or one location \>10 dB less than normal.
• The presence of a focal or diffuse area of optic disc rim loss, as shown by a reduction of optic rim thickness to less than one tenth of disc diameter at any point on the disc. (alternatively, optic disc which in the opinion of the patient's consultant shows glaucomatous changes as shown by focal or diffuse optic rim thinning)

You may not qualify if:

• Anterior segment neovascularisation
• Any intraocular epithelial ingrowth
• Retinal or optic nerve neovascularisation
• Aphakia
• Previous glaucoma filtering surgery
• Uveitis
• Any previous intraocular surgery
• Inability or unwillingness to give informed consent
• Inability or unwillingness to return for postoperative follow-up as prescribed in the trial regimen
• Unwillingness to accept randomisation
• Patient less than 40 years of age
• Chemotherapy in the 6 weeks prior to surgery
• Any other disease causing visual field loss or likely to cause field loss over the next three years e.g. diabetic retinopathy, pituitary disease or stroke.
• Pregnancy or female of childbearing age who may be pregnant at time of treatment. A pregnancy test will be performed on all women of childbearing age to rule out pregnancy.
• Cataract that is deemed significant enough to require surgery during the course of the trial or that makes field testing or optic disc recording by either photography or the scanning laser ophthalmoscope unreliable or not technically possible.

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle

Interventions

Fluorouracil; Sodium Chloride

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: December 20, 2024
• Study Start: April 1, 1996
• Primary Completion: June 1, 2000
• Study Completion: June 1, 2003
• Last Updated: December 20, 2024

Record last verified: 2024-12