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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Miss Felicia Ikeji
+44 20 7679 9506
cctu.naming@ucl.ac.uk


Prof David Garway-Heath
-
d.garway@ucl.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - NicotinAMide in Glaucoma (NAMinG): a randomised, placebo-controlled, multi-centre, Phase III trial
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NicotinAMide in Glaucoma (NAMinG): a randomised, placebo-controlled, multi-centre, Phase III trial

Recruiting

Open to: All Genders

Age: Adult

London Cambridge London Belfast Manchester Barnet Portsmouth Liverpool Nottingham East Grinstead

Medical Conditions

Open-angle glaucoma

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Glaucoma is a long-term eye disease which can cause permanent loss of sight and sometimes blindness. It is the world’s most common cause of irreversible blindness. Vision loss happens because of damage to the important nerve at the back of the eye called the optic nerve. Most people receiving current glaucoma treatments (eye drops or laser therapy) do not experience noticeable vision loss. However, a significant minority do lose vision. 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. There are 2 big risk factors of Glaucoma - being an older person and having high pressure inside the eye. High pressure damages the optic nerve and being older makes this damage more likely. Some people get glaucoma even if they have normal eye pressure so we think that the optic nerve in some people is more easily damaged. At the moment, we cannot tell who these people are. Recent research has looked at parts of cells called ‘mitochondria’. These produce energy and might affect how likely it is that vision could be damaged by eye pressure. The nerve cells in the eye need a great deal of energy to function and survive. Vitamin B3, also known as nicotinamide (NAM), may improve the way mitochondria work. This research study wants to know if NAM treatment can protect against people losing sight because of glaucoma getting worse.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

18 Jan 2024 31 May 2025

There will be two groups, but all will receive normal care to lower eye pressure (drops or laser); one group will receive NAM and the other group will receive dummy treatment (placebo). The trial will be randomised. Vision will be monitored through standard of care eye tests, questionnaires will be completed, blood tests will be required and there will be more visits to the hospital (3 extra than normal over 30 months). A successful outcome would lead to greatly reduced sight loss in glaucoma. Treatment with pills may also be easier for patients and would significantly reduce cost to NHS.
There is a total of 8 clinic visits, so 3 extra visits in addition to the participants routine visits. This has been reduced from the original concept so as not to be too onerous based on the feedback received from a patient web focus group. The visits, where possible, have been kept in line with normal routine care. Participants will be reimbursed (up to £30) for the travel costs incurred in attending the additional visits.


Patients aged 18 years or older, who have been recently diagnosed (within the last 12 months) with early to moderate open-angle glaucoma (OAG) in at least one eye.

You can take part if:



You may not be able to take part if:


1. Pigment dispersion glaucoma2. Pregnancy (or planned pregnancy during the trial) and/or breastfeeding3. 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.4. Current treatment with either isoniazid, pyrazinamide, carbamazepine, phenobarbital or primidone5. Current liver disease or laboratory results with elevated levels of liver transaminases (AST or ALT >3 x ULN) at screening visit.6. Renal failure (eGFR <30mL/min/1.73m²) at screening visit7. Conditions affecting both eyes*** which may affect the VF test result:a. Diabetic retinopathy or any other retinal disease causing VF lossb. Clinically relevant cataract (likely to require cataract surgery within the next 2 years)c. Dementia or other non-glaucomatous neurological disease causing VF lossd. Adnexal conditions causing VF loss (including, but not limited to blepharochalasis)8. Diagnosed with cancer in the last 5 years (with exception of non-melanoma skin cancer)9. Any clinical condition that, in the investigator’s opinion would make the participant unsuitable for the trial10. Concurrently enrolled in any other interventional trial or participation in previous clinical trial of glaucoma11. 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.

*** If only one eye is affected and the other is eligible, participant can still enter the trial.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Kings College Hospital
    King's College Hospital NHS Foundation Trust Denmark Hill
    London
    SE5 9RS
  • Addenbrookes
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ
  • Moorfields Eye Hospital
    162 City Road
    London
    EC1V 2PD
  • Belfast City Hospital
    51 Lisburn Rd
    Belfast
    BT9 7AB
  • Manchester Royal Eye Hospital
    Oxford Road
    Manchester
    M13 9WL
  • Barnet Hospital
    Wellhouse Lane
    Barnet
    EN5 3DJ
  • Queen Alexandra Hospital
    Southwick Hill Road Cosham
    Portsmouth
    PO6 3LY
  • Royal Liverpool University Hospital NHS Trust
    Royal Liverpool University Hospital Prescot Street
    Liverpool
    L7 8XP
  • Queens Medical Centre, Nottingham University Hospital
    Derby Road
    Nottingham
    NG7 2UH
  • Queen Victoria Hospital Cdc
    Holtye Road
    East Grinstead
    RH19 3DZ

Benefits:
There is no guarantee that the Nicotinamide treatment will benefit patients however, the information we get from the trial will help the trial team find out if Nicotinamide provides better outcomes for people with glaucoma and therefore, will improve treatment for all glaucoma patients in the future.
Risks:
Adverse Events/Side Effects:
Nicotinamide (NAM) is known to be well-tolerated and the great majority of people taking NAM at the doses prescribed in the trial have no side effects. A patient attendee from the web focus group mentioned that the trial is particularly attractive as the treatment is non-invasive with a low risk of side effects. However, in any clinical trial, there is a chance of experiencing side-effects from the trial medications. The possible (including very rare) side effects of NAM are: flushing, gastro-intestinal symptoms, liver function test abnormalities, eye symptoms, fatigue, headaches, and low insulin sensitivity. Participants will be informed of the risks during the informed consent process and they will be asked to record in their dosing dairy any side effects they experience, which will be reviewed regularly at each clinic visit. The research team will also be in constant contact with the participants via telephone calls scheduled in between the clinic visits. Participants will also be informed to notify the research team should they experience any serious side effects/serious adverse events or if they are hospitalised. Participants will be provided with an alert card, which they will carry with them at all times and it will contain contact details of the trial team during in-office/out-of-office hours.
There are some medications that can cause side-effects when taken with NAM. Participants will be asked to take all their medications, including supplements to their Screening visit so that the research team can review their concomitant medication before entering the trial. Participants will be instructed to inform the research team of all medications (prescribed and non-prescribed) that they take during the course of trial and this will be reviewed at each clinic visit. There are some medications that preclude the participant from entering the trial and the research team will inform the participant of this and this information will be detailed in the Participant Information Sheet (PIS). A Participant Medication Checklist Letter will also be provided to participants, alongside their appointment letter for their Screening visit as a reminder to bring all their medication and those medications that are not permitted in the trial.
We do not know if NAM is a risk for a pregnant woman, an unborn baby, or a breastfeeding child, so pregnant and breastfeeding women will not be allowed to take part in the trial. Male and female participants will be asked to take highly effective contraceptive measures during the course of the trial starting from the time of informed consent and for 30 days after their last administration of the trial drug. Urine pregnancy tests for women of child bearing potential (WOCBP) will be performed at each clinic visit.
The collection of blood samples can be uncomfortable, but rarely results in any serious problems. Reported side effects include feeling light-headed or faint, bruising and/or discomfort around the needle site. Every effort will be made by the research team to minimise this.
Visual field assessments occur during clinic visits as part of standard of care, however there are some trial visits where the visual field assessment is required to be repeated twice. A 30 minute break will be given in between these repeated tests to avoid long durations of assessing the eyes and to ensure the correct visual field tests are performed, a participant visual field reminder card will be supplied to the participant by the research team, which they can bring to each clinic visit and hand to the technician performing the visual field assessment.

Prof David Garway-Heath
-
d.garway@ucl.ac.uk


Miss Felicia Ikeji
+44 20 7679 9506
cctu.naming@ucl.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by UCL Comprehensive Clinical Trials Unit and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN16435278

Or CPMS 54918

Last updated 30 December 2024

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