At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Nicotinomide (drug), Matching placebo (drug)
- How long the study runs
- Study runs about 41 months (dates as stated)
- About the drug or intervention
- Nicotinomide — drug: Nicotinamide tablets (750mg) · Matching placebo — drug: Matching placebo
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 496
- Started
- 2024-01-18
- Last checked
- 2024-05
Plain English Summary
What is this study?
- • Testing a new treatment for glaucoma, open-angle
- • Phase3 - 496 participants
- • Glaucoma is the leading cause of sight impairment and blindness worldwide
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with glaucoma, open-angle
Where?
- • Belfast - Belfast City Hospital
- • Cambridge - Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
- • East Grinstead - Queen Victoria Hospital NHS Foundation Trust
- • Liverpool - Royal Liverpool Hospital
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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...
Who cannot take part
- ✗Pigment dispersion glaucoma
- ✗Pregnancy (or planned pregnancy during the trial) and/or breastfeeding
- ✗Current treatment with either isoniazid, pyrazinamide, carbamazepine, phenobarbital or primidone
- ✗Current liver disease or laboratory results with elevated levels of liver transaminases (liver enzymes or liver enzymes \>3 x ULN) at...
- ✗kidney failure (eGFR \<30mL/min/1.73m²) at screening visit.
See the full criteria
Where Is This Study? (10 UK sites)
Belfast City Hospital
Belfast BT9 7AB, United Kingdom
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 OQQ, United Kingdom
Queen Victoria Hospital NHS Foundation Trust
East Grinstead RH19 3DZ, United Kingdom
Royal Liverpool Hospital
Liverpool L7 8XP, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London EC1V 2PD, United Kingdom
Barnet Hospital, Royal Free London NHS Foundation Trust
London EN5 3DJ, United Kingdom
King's College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
Manchester Royal Eye Hospital
Manchester M13 9WL, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham NG7 2UH, United Kingdom
Queen Alexandra Hospital
Portsmouth PO6 3LY, United Kingdom
How to Get in Touch
NAMinG Trial Team
Sponsor contactCONTACT
Felicia Ikeji
Sponsor contactCONTACT
