GlaucomaPhase 3MoreFlowNCT06745856
Intraoperative 5-fluorouracil Augmentation of Trabeculectomy
A Phase 3 study testing 5-fluorouracil in people with Glaucoma and Primary Open Angle Glaucoma, run by Moorfields Eye Hospital NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma, Primary Open Angle Glaucoma
- What is being tested?
- 5-fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- No sites listed yet
- Study dates
- Apr 1996to Jun 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Anterior segment neovascularisation
- Any intraocular epithelial ingrowth
- Retinal or optic nerve neovascularisation
- Aphakia
- Previous glaucoma filtering surgery
- Uveitis
Show all 19Show fewer
- 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.
- Any medical condition likely to prevent the patient from regularly attending for the next three years
- Previous conjunctival surgery at proposed site of trabeculectomy
- Chronic use of topical or systemic steroids
- Previous squint surgery
About this study
Official title: A Trial of Intraoperative 5-fluorouracil in Primary Glaucoma Filtration Surgery: Effects on Long Term Intraocular Pressure Control and Disease Progression
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.
Read the detailed description
Glaucoma is the commonest cause of irreversible blindness worldwide. Treatment is initially with topical medication, but when the intraocular pressure is still poorly controlled, surgical treatment is required. The surgical treatment of choice remains the trabeculectomy and this is often augmented with antimetabolite.
The choice of antimetabolite varies between surgeons, as does the indications for use. Postoperative delivery of the drug can be uncomfortable for the patient and time consuming. This study examines the potential benefits and side effect profile of intraoperative 5FU compared to unaugmented trabeculectomy.
The patients are recruited from Moorfields Eye Hospital and followed up by the staff from the glaucoma department.
- Conditions
- Glaucoma, Primary Open Angle Glaucoma
- Being tested
- 5-fluorouracil, placebo
- Keywords
- glaucoma, trabeculectomy, intraocular pressure, randomized control study, antimetabolite, 5 fluorouracil
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracilDrug
Also called 5 fluorouracil subconjunctival injection
Subconjunctival, peroperative, application of 50mg/ml concentration of 5-fluoruracil.
placeboDrug
Also called sodium chloride solution (0.9%)"
Subconjunctival, peroperative application of normal saline (NaCl 0.9%)
| Study group | Role | What they receive |
|---|---|---|
| 5-fluorouracil | Active comparator | antimetabolite to prevent wound healing Receives: Drug: 5-fluorouracil |
| placebo | Placebo comparator | Subconjunctival placebo. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: a minimum of 3 years follow up
Secondary outcomes (1)
long term safety of intraoperative 5FU
A secondary objective was to examine the relationship between IOP control and glaucoma progression. IOP failure was defined in four categories ≤ 14mmHg, ≤ 17mmHg, ≤ 21mmHg or > 21mmHg. It was hypothesized that when compared to placebo, intraoperative 5FU would result in lower IOP levels and better control of IOP for at least 3 years reducing the risk of progression of visual field loss or optic nerve damage.
Measured: a minimum of 3 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study startApr 1996
- Primary completionJun 2000
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745856
- Sponsor's protocol ID
- G9330070
- Acronym
- MoreFlow
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Intraoperative 5-fluorouracil in Primary Glaucoma Filtration Surgery: Effects on Long Term Intraocular Pressure Control and Disease Progression
- ClinicalTrials.gov ID
- NCT06745856
- Acronym / sponsor ID
- MoreFlow / G9330070
- Conditions
- Glaucoma, Primary Open Angle Glaucoma
- Keywords
- glaucoma, trabeculectomy, intraocular pressure, randomized control study, antimetabolite, 5 fluorouracil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 1996
- Primary completion
- Jun 2000 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glaucoma is the commonest cause of irreversible blindness worldwide. Treatment is initially with topical medication, but when the intraocular pressure is still poorly controlled, surgical treatment is required. The surgical treatment of choice remains the trabeculectomy and this is often augmented with antimetabolite.
The choice of antimetabolite varies between surgeons, as does the indications for use. Postoperative delivery of the drug can be uncomfortable for the patient and time consuming. This study examines the potential benefits and side effect profile of intraoperative 5FU compared to unaugmented trabeculectomy.
The patients are recruited from Moorfields Eye Hospital and followed up by the staff from the glaucoma department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-fluorouracil | Active comparator | Drug: 5-fluorouracilantimetabolite to prevent wound healing |
| placebo | Placebo comparator | Drug: placeboSubconjunctival placebo. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (19 listed)
- Anterior segment neovascularisation
- Any intraocular epithelial ingrowth
- Retinal or optic nerve neovascularisation
- Aphakia
- Previous glaucoma filtering surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-fluorouracilAlso: 5 fluorouracil subconjunctival injectionSubconjunctival, peroperative, application of 50mg/ml concentration of 5-fluoruracil. | Drug | 5-fluorouracil |
| placeboAlso: sodium chloride solution (0.9%)"Subconjunctival, peroperative application of normal saline (NaCl 0.9%) | Drug | placebo |
Primary outcome
Glaucoma control
Time frame: a minimum of 3 years follow up
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.
1 secondary outcome
long term safety of intraoperative 5FU
Time frame: a minimum of 3 years follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-fluorouracil in people with Glaucoma and Primary Open Angle Glaucoma, run by Moorfields Eye Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glaucoma control (time frame: a minimum of 3 years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.