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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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, normal tension glaucoma (NTG) and pseudoexfoliation glaucoma)

• Open angle on gonioscopy

• Adults aged 18 years or over

• Snellen visual acuity 6/12 or better in at least one eye meeting the visual field (VF) criteria

• Visual Field (VF) mean deviation (MD) no worse than -12dB in either eye

• A negative pregnancy test result at the screening and baseline visit prior to randomisation for women of childbearing potential

• Ability to provide informed consent to participate

• Able and willing to attend trial visits and comply with trial procedures for the duration of the trial

Locations
Other Locations
United Kingdom
Belfast City Hospital
NOT_YET_RECRUITING
Belfast
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Cambridge
Queen Victoria Hospital NHS Foundation Trust
RECRUITING
East Grinstead
Royal Liverpool Hospital
NOT_YET_RECRUITING
Liverpool
Barnet Hospital, Royal Free London NHS Foundation Trust
NOT_YET_RECRUITING
London
King's College Hospital NHS Foundation Trust
RECRUITING
London
Moorfields Eye Hospital NHS Foundation Trust
RECRUITING
London
Manchester Royal Eye Hospital
NOT_YET_RECRUITING
Manchester
Nottingham University Hospitals NHS Trust
NOT_YET_RECRUITING
Nottingham
Queen Alexandra Hospital
RECRUITING
Portsmouth
Contact Information
Primary
NAMinG Trial Team
cctu.naming@ucl.ac.uk
0203 108 6148
Backup
Felicia Ikeji
f.ikeji@ucl.ac.uk
020 7679 9506
Time Frame
Start Date: 2024-01-18
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 496
Treatments
Experimental: Nicotinamide
Participants will receive Nicotinamide for up to 27 months (treatment period) in addition to an initial treatment of Standard of Care IOP- lowering therapy (prior to randomisation and start of trial treatment) . They will receive 1.5g/day for the first 6 weeks, then dose increase to 3.0g/day for remainder of the treatment period.
Placebo_comparator: Matching Placebo
Participants will receive matching placebo for up to 27 months (treatment period) in addition to an initial treatment of Standard of Care IOP- lowering therapy (prior to randomisation and start of trial treatment) . They will receive 1.5g/day for the first 6 weeks, then dose increase to 3.0g/day for remainder of the treatment period.
Authors
David Garthway-Heath, David Broadway
Sponsors
Leads: University College, London
Collaborators: National Institute for Health Research, United Kingdom

This content was sourced from clinicaltrials.gov

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