Nicotinamide in Glaucoma (NAMinG)

  • Research type

    Research Study

  • Full title

    Nicotinamide in Glaucoma (NAMinG); A randomised, placebo-controlled, multi-centre, Phase III trial

  • IRAS ID

    1006433

  • Contact name

    Gemma Jones

  • Contact email

    gemma.jones@ucl.ac.uk

  • Sponsor organisation

    UCL Comprehensive Clinical Trials Unit

  • ISRCTN Number

    ISRCTN16435278

  • Clinicaltrials.gov Identifier

    NCT05405868

  • Research summary

    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 vison 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. There will be two groups, but all we 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 sigh loss in glaucoma. Treatment with pills may also be easier for patients and would significantly reduce cost to NHS.

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    23/EM/0175

  • Date of REC Opinion

    6 Nov 2023

  • REC opinion

    Further Information Favourable Opinion