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RECRUITING
NCT05405868
PHASE3

Nicotinamide in Glaucoma (NAMinG): A Randomised, Placebo-controlled, Multi-centre, Phase III Trial

Sponsor: University College, London

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

496

Start Date

2024-01-18

Completion Date

2027-06-30

Last Updated

2024-05-09

Healthy Volunteers

No

Interventions

DRUG

Nicotinomide

Nicotinamide tablets (750mg)

DRUG

Matching placebo

Matching placebo

Locations (10)

Belfast City Hospital

Belfast, Northern Ireland, United Kingdom

Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Queen Victoria Hospital NHS Foundation Trust

East Grinstead, United Kingdom

Royal Liverpool Hospital

Liverpool, United Kingdom

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Barnet Hospital, Royal Free London NHS Foundation Trust

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

Manchester Royal Eye Hospital

Manchester, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Queen Alexandra Hospital

Portsmouth, United Kingdom