NAMinG

Trial status: Closed to Recruitment
Funder: NIHR EME
ClinicalTrials.gov: NCT05405868
REC: 23/EM/0175
ISRCTN: ISRCTN16435278
 

Trial Information

Glaucoma is a long-term eye disease which causes loss of vision. Open-angle glaucoma (OAG) is the most common type of glaucoma. Vision loss happens because of damage to an important nerve at the back of the eye called the optic nerve. There are two big risk factors: 1) being an older person and 2) having high pressure inside the eye (intraocular pressure (IOP)). Current treatment options include eye drops or laser therapy to lower the eye pressure. We cannot cure glaucoma but we can treat it so that the damage is slowed down or stopped, so more vision is kept for longer. Recent research has looked at cells called 'mitochondria'.

These cells produce energy in our 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 NAMinG trial aims to investigate whether taking high dose NAM (3.0g a day) in addition to standard of care IOP lowering treatment, can reduce the amount of visual loss in glaucoma patients, compared with those who receive placebo (dummy treatment, no NAM). This is a randomised, double-masked, placebo-controlled trial which has aimed to recruit 376 participants aged 18 years and over from 12 NHS hospitals across the UK who have been diagnosed within the last five years with early to moderate open-angle glaucoma.The recruitment period ended in April 2026 and the recruitment target was met with 378 patients randomised.

Following a screening visit, eligible participants attended a baseline visit where they were randomly allocated into either the NAM group or the placebo group. Each group undergoes the same assessments and take either oral NAM or matching placebo tablets daily for 27 months. Participation in the trial will be up to a maximum of 30 months attending a total of 8 clinic visits (5 of which will be in line with normal routine care). All Participants' will receive at least four telephone calls during the 30 month period to capture trial medication compliance and safety reporting.The trial will conclude in November 2028 with the results to be disseminated within 12 months The trial is being funded by the National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme, grant number 132758.

Trial locations

Moorfields Eye Hospital, London 
PI: Professor David Garway-Heath 
Email: d.garwayheath@nhs.net 

Kings College Hospital, London 
PI: Mr Gerassimos Lascaratos 
Email: gerassimos.lascaratos@nhs.net 

Portsmouth Hospitals University, Portsmouth 
PI: Mr James Kirwan 
Email: jfkirwan@mac.com 

Addenbrooke's Hospital, Cambridge 
PI:Miss Tasneem Khatib
Email: tasneem.khatib@nhs.net

Nottingham University Hospitals, Nottingham 
PI: Professor Anthony King 
Email: anthony.king@nottingham.ac.uk 

Belfast City Hospital, Belfast 
PI: Professor Augusto Azuara-Blanco 
Email: a.azuara-blanco@qub.ac.uk 

Queen Victoria Hospital NHS Foundation Trust, East Grinstead
PI: Mr Gokulan Ratnarajan
Email: Gokulan.ratnarajan@nhs.net

Manchester Royal Eye Hospital, Manchester
PI: Mr Jonathan Yu
Email: Jonathan.yu@mft.nhs.uk

Royal Liverpool Hospital, Liverpool
PI: Ms Neeru Vallabh
Email: vallabh@liverpool.ac.uk

Barnet Hospital (Royal Free London NHS Foundation Trust), London
PI: Mr Ameet Shah
Email: ameet.shah1@nhs.net

Sunderland Eye Infirmary, Sunderland
PI: Mr Karim El-Assal
Email: karim.el-assal@nhs.net

Central Middlesex Hospital, London
PI: Mr Zain Juma
Email: z.juma@nhs.net

 

 

Meet the NAMinG Team

Professor David Garway-Heath
Chief Investigator

Mr Gerassimos Lascaratos
Co-Chief Investigator

Nicola Harris
Clinical Project Manager

Aneet Gill
Clinical Trial Manager

 

Inclusion Criteria

1. Patients with early to moderate open-angle glaucoma (OAG) in at least one eye (including primary OAG, NTG and pseudoexfoliation glaucoma) diagnosed within the last 5 years.
2. Open angle on gonioscopy or anterior segment optical coherence tomography (OCT)
3. Adults aged 18 years or over 
4. Snellen visual acuity 6/12 or better in at least one eye meeting the visual field (VF) criteria 
5. Glaucomatous Visual Field (VF) loss with mean deviation (MD) no worse than -12dB in either eye (mean value of the Screening and last reliable routine clinic visit VFs)
6. A negative pregnancy test result at the screening and baseline visit prior to randomisation for women of childbearing potential
7. Ability to provide informed consent to participate 
8. Able and willing to attend trial visits and comply with trial procedures for the duration of the trial

Exclusion Criteria

1. Pigment dispersion glaucoma 
2. Previous bleb-forming glaucoma surgery (including trabeculectomy, non-penetrating procedures and drainage tube surgery, with or without a plate)
3. Intraocular surgery within the last 3 month
4. Pregnancy (or planned pregnancy during the trial) and/or breastfeeding 
5. Women of childbearing potential and male participants with a partner of childbearing potential not willing to use highly effective contraception as described in the protocol for the duration of the trial treatment and for the time period specified following last trial treatment administration. 
6. Current treatment with either isoniazid, pyrazinamide, carbamazepine, phenobarbital or primidone
7. Current liver disease or laboratory results with elevated levels of transaminases (AST or ALT >3 x ULN) at screening visit.
8. Renal failure (eGFR <30mL/min) at screening visit
9. Conditions affecting both eyes which may affect the Visual Field test result:

a.    Diabetic retinopathy or any other retinal disease causing VF loss
b.    Clinically relevant cataract (likely to require cataract surgery within the next 2 years)
c.    Dementia or other non-glaucomatous neurological disease causing VF loss
d.    Adnexal conditions causing VF loss (including, but not limited to blepharochalasis)

10. Diagnosed with cancer in the last 5 years (with exception of non-melanoma skin cancer)

11. Any clinical condition that, in the investigator’s opinion would make the participant unsuitable for the trial

12. Concurrently enrolled in any other interventional trial or participation in previous clinical trial of glaucoma

13. 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

Publications

• tbc

Contact
email: cctu.naming@ucl.ac.uk

NAMinG Trial Team
Comprehensive Clinical Trials Unit at UCL
90 High Holborn
2nd Floor
London
WC1V 6LJ