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NAMinG

NAMinG : A Phase II/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

12 January 2022

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Trial status: In set-up
Funder: NIHR EME
EudraCT: 2021-006867-58
ClinicalTrials.gov: TBC
REC: TBC
ISRCTN: N/A

 

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 will aim to recruit 496 participants aged 18 years and over from 7 NHS hospitals across the UK who have been recently diagnosed (within the last 12 months) with open-angle glaucoma.

Following a screening visit, eligible participants will attend a baseline visit where they will be randomly allocated into either the NAM group or the placebo group. Each group will undergo 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 is being funded by the National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme, grant number 132758.

Sites

(Not yet open)
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: Professor Rupert Bourne 
Email: rb@rupertbourne.co.uk 

Norfolk & Norwich University Hospitals, Norwich 
PI: Professor David Broadway 
Email: david.broadway@nnuh.nhs.uk 

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 

Meet the NAMinG Team

Professor David Garway-Heath

Chief Investigator

 

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Mr Gerassimos Lascaratos

Co-Lead Investigator

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Felicia Ikeji

Clinical Project Manager

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Nazma Begum-Ali

Clinical Trial Manager

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Zainab Mohamed

Data Manager

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Inclusion Criteria
  1. 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, NTG and pseudoexfoliation glaucoma) 
  2. Open angle on gonioscopy 
  3. Male or female 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. Visual Field (VF) mean deviation (MD) no worse than -12dB in either eye 
  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. Pregnancy (or planned pregnancy during the trial) and/or breastfeeding 
    3. Women of childbearing potential and male participants with a partner of childbearing potential not willing to use highly effective contraception as described in section 6.3.1.5 for the duration of the trial treatment and for the time period specified following last trial treatment administration. 
    4. Current treatment with isoniazid or pyrazinamide or carbamazepine
    5. Current liver disease or laboratory results with elevated levels of transaminases (AST or ALT >3 x ULN) at screening visit.
    6. Renal failure (eGFR <30mL/min) at screening visit
    7. Conditions which may interfere with VF testing:

    a.    Diabetic retinopathy or any other retinal ocular 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)

    1. Any clinical condition that, in the investigator’s opinion would make the participant unsuitable for the trial
    2. Concurrently enrolled in any other interventional trial or participation in previous clinical trial of glaucoma
    3. Current use of, or 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

     

      CCTU

      The Comprehensive Clinical Trials Unit (CCTU) at UCL will design, conduct, analyse and report high quality clinical trials and other well designed studies that fit with the research strategies of UCL and UCL Partners. In pursuit of this Mission, the UCL Comprehensive Clinical Trials Unit will:

      • Develop partnerships with clinical investigators at all relevant institutions
      • Promote a trial governance structure that supports a compliant, risk-based, proportional approach to the application of regulations

      The UCL CCTU will accomplish its mission through CCTU staff and collaborators supporting adoption of its policies and procedures:

      • Provide clinical trials leadership and expertise across the whole range of activities required to deliver trials from concept to dissemination and implementation of research findings
      • Employ highly experienced staff with diverse research interests and expertise in clinical trial methodology to enhance the effectiveness of the research pathway
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