Glaucoma, Open-AnglePhase 3NAMinGNCT05405868
Nicotinamide in Glaucoma (NAMinG): A Randomised, Placebo-controlled, Multi-centre, Phase III Trial
A Phase 3 study testing Nicotinomide in people with Glaucoma, Open-Angle, run by University College, London at 10 sites in United Kingdom.
Trial summary
Glaucoma is the leading cause of sight impairment and blindness worldwide. It is a long-term eye disease which can cause permanent loss of sight and sometimes blindness and affects 1 in 50 people over 50 years of age. Open-angle glaucoma (OAG) is the most common type of glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Nicotinomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 496 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- 18 Jan 2024to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been recently diagnosed (within the last 12 months) with early to moderate open-angle glaucoma (OAG) in at least one eye (including primary OAG, normal tension glaucoma (NTG) and pseudoexfoliation glaucoma)
- Open angle on gonioscopy
- Adults aged 18 years or over
- Snellen visual acuity 6/12 or better in at least one eye meeting the visual field (VF) criteria
- Visual Field (VF) mean deviation (MD) no worse than -12dB in either eye
- A negative pregnancy test result at the screening and baseline visit prior to randomisation for women of childbearing potential
- Ability to provide informed consent to participate
- Able and willing to attend trial visits and comply with trial procedures for the duration of the trial
Who cannot join
- Pigment dispersion glaucoma
- Pregnancy (or planned pregnancy during the trial) and/or breastfeeding
- Women of childbearing potential and male participants with a partner of childbearing potential not willing to use highly effective contraception for the duration of the trial treatment and for the time period specified following last trial treatment administration.
- Current treatment with either isoniazid, pyrazinamide, carbamazepine, phenobarbital or primidone
- Current liver disease or laboratory results with elevated levels of liver transaminases (AST or ALT >3 x ULN) at screening visit.
- Renal failure (eGFR <30mL/min/1.73m²) at screening visit.
Show all 15Show fewer
- Conditions affecting both eyes which may affect the Visual Field test result:
- Diabetic retinopathy or any other retinal disease causing VF loss
- Clinically relevant cataract (likely to require cataract surgery within the next 2 years)
- Dementia or other non-glaucomatous neurological disease causing VF loss
- Adnexal conditions causing VF loss (including but not limited to blepharochalasis)
- Diagnosed with cancer in the last 5 years (with exception of non-melanoma skin cancer).
- Any clinical condition that, in the investigator's opinion would make the participant unsuitable for the trial.
- Concurrently enrolled in any other interventional trial or participation in previous clinical trial of glaucoma.
- Current use of, and unwilling to abstain from, over-the-counter additional vitamin B3/NAM oral supplements (including skin preparations such as ointments/emulsions), Ginkgo Biloba and/or Coenzyme Q10 supplements, throughout the duration of their participation in the trial.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United Kingdom10 sites, 10 recruiting
- Not yet recruiting
Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB
Augusto Azuara-Blanco
- Not yet recruiting
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 OQQ
Rupert Bourne
- Recruiting
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, RH19 3DZ
Gokulan Ratnarajan
- Not yet recruiting
Royal Liverpool Hospital
Liverpool, L7 8XP
Neeru Vallabh
- Recruiting
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
David Garway-Heath
- Not yet recruiting
Barnet Hospital, Royal Free London NHS Foundation Trust
London, EN5 3DJ
Ameet Shah
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Gerassimos Lascaratos
- Not yet recruiting
Manchester Royal Eye Hospital
Manchester, M13 9WL
Jonathan Yu
- Not yet recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Anthony King
- Recruiting
Queen Alexandra Hospital
Portsmouth, PO6 3LY
James Kirwan
About this study
Official title: A Phase III, Double-masked, Randomised, Placebo-controlled Trial Investigating the Safety and Efficacy of Nicotinamide (NAM) to Slow Visual Field Loss in Adults With Open-angle Glaucoma
Glaucoma is the leading cause of sight impairment and blindness worldwide. It is a long-term eye disease which can cause permanent loss of sight and sometimes blindness and affects 1 in 50 people over 50 years of age. Open-angle glaucoma (OAG) is the most common type of glaucoma. This tends to develop slowly over many years, caused by the drainage pathway in the eye gradually becoming blocked over time due to a build-up of fluid. This build-up causes pressure in the eye to increase (intra-ocular pressure (IOP)), which then damages the important nerve at the back of the eye called the optic nerve, resulting in vision loss. Current treatments offered for glaucoma (eye drops or laser surgery), aim to lower eye pressure and have shown to slow vision loss, however, visual disability and blindness rates remain unacceptably high and many patients continue to lose vision despite these treatments, suggesting that the optic nerve in some patients is more easily damaged. Recent research has looked at cells called 'mitochondria'. These cells produce most of the energy in the body, and the nerve cells in the eye need a lot of energy to function and survive. Nicotinamide (NAM) is a form of Vitamin B3 and evidence so far has shown that mitochondrial function can be improved with this treatment. The aim of this trial is to find out whether taking oral NAM when used with current standard treatment for lowering pressure in the eye, can reduce the amount of sight loss in recently diagnosed patients with OAG, and evaluate the long-term safety and effectiveness of NAM. The trial will use two groups of people recently diagnosed with glaucoma and who have normal care (drops or laser) to lower eye pressure. Using a method of randomisation (randomly allocated to each group using a computer system), one group will be given NAM and the other group will be given a placebo or 'dummy pill'. This is a double masked trial meaning the participant nor the Investigator will be told which treatment group patients have been allocated to.
Read the detailed description
Open Angle Glaucoma (OAG) is a chronic optic neuropathy causing progressive vision loss. It is well established that IOP is the only currently modifiable risk factor for glaucoma progression, and it is widely accepted that other risk factors modulate the susceptibility of an eye to IOP. This has led to a considerable body of research into neurodegenerative mechanisms and potential neuroprotective approaches. Various pathways contributing to the neurodegeneration have been implicated, and many have focussed on the role of mitochondria. Neuroprotection would significantly reduce sight loss and the burden of IOP-lowering eye drop treatment needed for disease control. There is evidence that susceptibility to IOP is related to mitochondrial function and ageing is associated with mitochondrial functional decline. The knowledge gap addressed in this trial is the relative contribution that mitochondrial function makes to glaucomatous neurodegeneration and whether boosting mitochondrial function with NAM slows progression in humans in the same way that it does in animal models. Biomarkers for mitochondrial-related susceptibility have not yet been established in humans. The proposal therefore is a new mechanism neuroprotection to improve resistance to eye pressure and evaluate the long-term safety and efficacy of NAM to preserve vision and its mechanism of action. There is strong evidence that mitochondrial dysfunction is associated with OAG susceptibility and that NAM improves mitochondrial function. Research has shown short-term vision improvement with high-dose NAM in glaucoma patients. NAM is safe and well-tolerated.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Nicotinomide, Matching placebo
- Keywords
- Nicotinamide, Vitamin B3
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotinomideDrug
Nicotinamide tablets (750mg)
Matching placeboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide | Experimental | Participants will receive Nicotinamide for up to 27 months (treatment period) in addition to an initial treatment of Standard of Care IOP- lowering therapy (prior to randomisation and start of trial treatment) . They will receive 1.5g/day for the first 6 weeks, then dose increase to 3.0g/day for remainder of the treatment period. Receives: Drug: Nicotinomide |
| Matching Placebo | Placebo comparator | Participants will receive matching placebo for up to 27 months (treatment period) in addition to an initial treatment of Standard of Care IOP- lowering therapy (prior to randomisation and start of trial treatment) . They will receive 1.5g/day for the first 6 weeks, then dose increase to 3.0g/day for remainder of the treatment period. Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the treatment arms in change of Visual Field (VF) mean deviation (MD) at 27 months measured by the Humphrey Visual Field Analyser test
The Humphrey Visual Field Analyser test is a diagnostic tool commonly used to assess the retina's ability to detect a light stimulus at specific points within the visual field, called retinal sensitivity. Participants will undergo visual field testing at Screening, Baseline, Months 3, 6,12,18, 24 and Month 27 using the Humphrey Visual Field analyser with the SITA Standard 24-2 programme. The results will be used to measure the progression of vision loss between the active arm (Nicotinamide) and the comparator (matching placebo) The primary endpoint will be analysed using a linear mixed model to estimate the difference between treatment groups in VF MD at 27 months. The model will include month 27 VF MD as the outcome and baseline VF MD, IOP-lowering treatment type (eye drops vs laser) and baseline serum NAM levels as covariates.
Measured: Month 27; end of trial treatment
Secondary outcomes (7)
The difference in Visual Field (VF) mean deviation (MD) at 3 months (0-3 months - neuro-recovery) between the active treatment group and the placebo group, measured using the Humphrey Visual Field analyser test with the SITA Standard 24-2 programme
The Humphrey Visual Field Analyser test is a diagnostic tool commonly used to assess the retina's ability to detect a light stimulus at specific points within the visual field, called retinal sensitivity. Participants will undergo visual field testing using the Humphrey Visual Field analyser with the SITA Standard 24-2 programme. The results will be used to measure the progression of vision loss between the active arm (Nicotinamide) and the comparator (matching placebo) over the initial 0-3 months
Measured: From Baseline until Month 3
Quality-of-Life outcome differences between the two treatment groups at baseline, month 3 and month 27, as measured by the descriptive system for health-related quality of life, EQ-5D-5L with additional vision specific questions.
The EQ-5D-5L (with vision bolt-on) is a participant self-reported questionnaire which evaluates the generic quality of life at the time of completion. It comprises of one question for each of the five dimensions; no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A Visual Analogue Scale is also used and is a scale measured from 0 -100 scale where patients are asked to indicate their overall health on the day of questionnaire completion.
This version of the questionnaire will also include additional vision related questions as part of the 5 dimensions, known as vision bolt on questions.
Measured: At Baseline, Month 3 and Month 27
Quality-of-Life outcome differences between the two treatment groups at baseline, month 3 and month 27, as measured by the 15-item Glaucoma Quality of Life Questionnaire.
The Glaucoma Quality of Life Questionnaire (GQL-15) is a 15-item which measures the severity of visual disability and comprises of 15 vision-related items. The item-level responses for each factor are coded on a five-point scale (1 meaning no difficulty and 5 meaning severe difficulty), while 0 is marked if the participant does not perform the activity as a result of non-visual cause. These items are grouped into four subscales: 1) "Central and near vision" (two items); 2) "Peripheral vision" (six items); 3) "Dark adaptation and glare" (six items); and 4) "Outdoor mobility" (one item). Total score is derived by summing all item-level response scores.
Measured: At Baseline, Month 3 and Month 27
The safety profile of high dose NAM, measured by liver function tests (LFTs) at Screening, Month 3 and Month 18
The Liver Function test is a standard diagnostic laboratory assay used to diagnose and monitor liver disease or damage. The tests measure the levels of certain enzymes and proteins in the blood.
Measured: At Screening, Month 3 and Month 18
The safety profile of high dose NAM, measured from blood glucose test, HbA1c at Screening, Month 3 and Month 18
The HbA1c blood test is a standard diagnostic laboratory test used to measure blood sugar levels.
Measured: At Screening, Month 3 and Month 18
The safety profile of high dose NAM, measured by estimated glomerular filtration rate (eGFR) at Screening, Month 3 and Month 18
The eGFR blood test is a standard diagnostic laboratory test used to measure how well the kidney function is.
Measured: At Screening, Month 3 and Month 18
The number of adverse events as assessed by CTCAE v5.0 from baseline to month 27
Number of participants with treatment related adverse events assessed by CTCAE v5.0 from baseline to month 27.
Measured: From Baseline until end of trial treatment and trial completion at Month 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start18 Jan 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Model description
- Eligible participants will be randomised 1:1 to receive oral Nicotinamide 3g/day or matching Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- David Garway-Heath, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405868
- Sponsor's protocol ID
- CTU/2020/365
- Acronym
- NAMinG
- Status last verified
- May 2024
- First submitted
- 25 Feb 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD has been made at this time
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-masked, Randomised, Placebo-controlled Trial Investigating the Safety and Efficacy of Nicotinamide (NAM) to Slow Visual Field Loss in Adults With Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT05405868
- Acronym / sponsor ID
- NAMinG / CTU/2020/365
- Conditions
- Glaucoma, Open-Angle
- Keywords
- Nicotinamide, Vitamin B3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jun 2022 (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.
Glaucoma is the leading cause of sight impairment and blindness worldwide. It is a long-term eye disease which can cause permanent loss of sight and sometimes blindness and affects 1 in 50 people over 50 years of age. Open-angle glaucoma (OAG) is the most common type of glaucoma. This tends to develop slowly over many years, caused by the drainage pathway in the eye gradually becoming blocked over time due to a build-up of fluid. This build-up causes pressure in the eye to increase (intra-ocular pressure (IOP)), which then damages the important nerve at the back of the eye called the optic nerve, resulting in vision loss. Current treatments offered for glaucoma (eye drops or laser surgery), aim to lower eye pressure and have shown to slow vision loss, however, visual disability and blindness rates remain unacceptably high and many patients continue to lose vision despite these treatments, suggesting that the optic nerve in some patients is more easily damaged. Recent research has looked at cells called 'mitochondria'. These cells produce most of the energy in the body, and the nerve cells in the eye need a lot of energy to function and survive. Nicotinamide (NAM) is a form of Vitamin B3 and evidence so far has shown that mitochondrial function can be improved with this treatment. The aim of this trial is to find out whether taking oral NAM when used with current standard treatment for lowering pressure in the eye, can reduce the amount of sight loss in recently diagnosed patients with OAG, and evaluate the long-term safety and effectiveness of NAM. The trial will use two groups of people recently diagnosed with glaucoma and who have normal care (drops or laser) to lower eye pressure. Using a method of randomisation (randomly allocated to each group using a computer system), one group will be given NAM and the other group will be given a placebo or 'dummy pill'. This is a double masked trial meaning the participant nor the Investigator will be told which treatment group patients have been allocated to.
Detailed description
Open Angle Glaucoma (OAG) is a chronic optic neuropathy causing progressive vision loss. It is well established that IOP is the only currently modifiable risk factor for glaucoma progression, and it is widely accepted that other risk factors modulate the susceptibility of an eye to IOP. This has led to a considerable body of research into neurodegenerative mechanisms and potential neuroprotective approaches. Various pathways contributing to the neurodegeneration have been implicated, and many have focussed on the role of mitochondria. Neuroprotection would significantly reduce sight loss and the burden of IOP-lowering eye drop treatment needed for disease control. There is evidence that susceptibility to IOP is related to mitochondrial function and ageing is associated with mitochondrial functional decline. The knowledge gap addressed in this trial is the relative contribution that mitochondrial function makes to glaucomatous neurodegeneration and whether boosting mitochondrial function with NAM slows progression in humans in the same way that it does in animal models. Biomarkers for mitochondrial-related susceptibility have not yet been established in humans. The proposal therefore is a new mechanism neuroprotection to improve resistance to eye pressure and evaluate the long-term safety and efficacy of NAM to preserve vision and its mechanism of action. There is strong evidence that mitochondrial dysfunction is associated with OAG susceptibility and that NAM improves mitochondrial function. Research has shown short-term vision improvement with high-dose NAM in glaucoma patients. NAM is safe and well-tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomised 1:1 to receive oral Nicotinamide 3g/day or matching Placebo
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide | Experimental | Drug: NicotinomideParticipants will receive Nicotinamide for up to 27 months (treatment period) in addition to an initial treatment of Standard of Care IOP- lowering therapy (prior to randomisation and start of trial treatment) . They will receive 1.5g/day for the first 6 weeks, then dose increase to 3.0g/day for remainder of the treatment period. |
| Matching Placebo | Placebo comparator | Drug: Matching placeboParticipants will receive matching placebo for up to 27 months (treatment period) in addition to an initial treatment of Standard of Care IOP- lowering therapy (prior to randomisation and start of trial treatment) . They will receive 1.5g/day for the first 6 weeks, then dose increase to 3.0g/day for remainder of the treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who have been recently diagnosed (within the last 12 months) with early to moderate open-angle glaucoma (OAG) in at least one eye (including primary OAG, normal tension glaucoma (NTG) and pseudoexfoliation glaucoma)
- Open angle on gonioscopy
- Adults aged 18 years or over
- Snellen visual acuity 6/12 or better in at least one eye meeting the visual field (VF) criteria
- Visual Field (VF) mean deviation (MD) no worse than -12dB in either eye
Key exclusion criteria (15 listed)
- Pigment dispersion glaucoma
- Pregnancy (or planned pregnancy during the trial) and/or breastfeeding
- Women of childbearing potential and male participants with a partner of childbearing potential not willing to use highly effective contraception for the duration of the trial treatment and for the time period specified following last trial treatment administration.
- Current treatment with either isoniazid, pyrazinamide, carbamazepine, phenobarbital or primidone
- Current liver disease or laboratory results with elevated levels of liver transaminases (AST or ALT >3 x ULN) at screening visit.
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 |
|---|---|---|
| NicotinomideNicotinamide tablets (750mg) | Drug | Nicotinamide |
| Matching placeboMatching placebo | Drug | Matching Placebo |
Primary outcome
The difference between the treatment arms in change of Visual Field (VF) mean deviation (MD) at 27 months measured by the Humphrey Visual Field Analyser test
Time frame: Month 27; end of trial treatment
The Humphrey Visual Field Analyser test is a diagnostic tool commonly used to assess the retina's ability to detect a light stimulus at specific points within the visual field, called retinal sensitivity. Participants will undergo visual field testing at Screening, Baseline, Months 3, 6,12,18, 24 and Month 27 using the Humphrey Visual Field analyser with the SITA Standard 24-2 programme. The results will be used to measure the progression of vision loss between the active arm (Nicotinamide) and the comparator (matching placebo) The primary endpoint will be analysed using a linear mixed model to estimate the difference between treatment groups in VF MD at 27 months. The model will include month 27 VF MD as the outcome and baseline VF MD, IOP-lowering treatment type (eye drops vs laser) and baseline serum NAM levels as covariates.
7 secondary outcomes
The difference in Visual Field (VF) mean deviation (MD) at 3 months (0-3 months - neuro-recovery) between the active treatment group and the placebo group, measured using the Humphrey Visual Field analyser test with the SITA Standard 24-2 programme
Time frame: From Baseline until Month 3
Quality-of-Life outcome differences between the two treatment groups at baseline, month 3 and month 27, as measured by the descriptive system for health-related quality of life, EQ-5D-5L with additional vision specific questions.
Time frame: At Baseline, Month 3 and Month 27
Quality-of-Life outcome differences between the two treatment groups at baseline, month 3 and month 27, as measured by the 15-item Glaucoma Quality of Life Questionnaire.
Time frame: At Baseline, Month 3 and Month 27
The safety profile of high dose NAM, measured by liver function tests (LFTs) at Screening, Month 3 and Month 18
Time frame: At Screening, Month 3 and Month 18
The safety profile of high dose NAM, measured from blood glucose test, HbA1c at Screening, Month 3 and Month 18
Time frame: At Screening, Month 3 and Month 18
The safety profile of high dose NAM, measured by estimated glomerular filtration rate (eGFR) at Screening, Month 3 and Month 18
Time frame: At Screening, Month 3 and Month 18
The number of adverse events as assessed by CTCAE v5.0 from baseline to month 27
Time frame: From Baseline until end of trial treatment and trial completion at Month 27
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. No plan to share IPD has been made at this time
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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.
David Garway-Heath principal investigator
UCL
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicotinomide in people with Glaucoma, Open-Angle, run by University College, London at 10 sites in United Kingdom.
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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NAMinG Trial Team (0203 108 6148, cctu.naming@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the treatment arms in change of Visual Field (VF) mean deviation (MD) at 27 months measured by the Humphrey Visual Field Analyser test (time frame: Month 27; end of trial treatment). 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 9 May 2024.