RecruitingPHASE3INTERVENTIONAL

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

This study, called NAMinG, is investigating a new approach to managing open-angle glaucoma, a common eye disease that can lead to permanent sight loss. It affects your vision by damaging the optic nerve, often due to high pressure inside the eye. Current treatments lower this pressure, but some people still lose sight. Researchers are looking at Nicotinamide (NAM), a form of Vitamin B3. Early findings suggest NAM might improve how certain cells in the eye, called mitochondria, work – these cells are vital for the optic nerve's health. The study wants to find out if taking NAM pills alongside usual glaucoma treatments can reduce further sight loss in newly diagnosed patients and if it's safe over the long term.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University College, London

Enrolment target

496

Start

18 Jan 2024

Estimated completion

30 Jun 2027

Glaucoma, Open-Angle

What is this study about?

Glaucoma is a common eye condition that can slowly steal your sight and is a major cause of blindness worldwide. It's often called the 'silent thief of sight' because it usually doesn't cause pain or noticeable symptoms until vision loss has already happened. The most common type is open-angle glaucoma, which develops over many years. It happens when the fluid that normally drains from your eye doesn't leave properly, causing pressure to build up. This increased pressure then damages the optic nerve, which is like the cable connecting your eye to your brain. This damage eventually leads to vision loss.

You might be wondering why new treatments are needed if we already have eye drops and laser treatments. While current treatments are good at lowering eye pressure and slowing down vision loss, some people still continue to lose their sight. This suggests that the optic nerve in some individuals might be more sensitive to damage, even when eye pressure is controlled. Scientists have been investigating other factors, like tiny power-houses in our cells called 'mitochondria'. These mitochondria produce almost all the energy our bodies need, and the nerve cells in your eye require a lot of energy to stay healthy and function well.

This is where Nicotinamide (NAM), a type of Vitamin B3, comes in. Previous research has hinted that NAM can improve how these important mitochondria work. The NAMinG study is designed to explore if taking NAM alongside your usual glaucoma treatment can help protect your vision. We want to see if it can reduce the amount of sight loss in people who have recently been diagnosed with open-angle glaucoma. The study will also carefully check for any long-term side effects and how well NAM works over time.

Key takeaways

Tests if Vitamin B3 (Nicotinamide) can protect vision in glaucoma.
For people recently diagnosed with open-angle glaucoma.
Uses a 'dummy pill' (placebo) for fair comparison.
You continue your usual glaucoma treatment.
Aims to find out if NAM is safe and slows sight loss.
Participation involves regular clinic visits and eye tests.

Who may be eligible?

This study is looking for adults aged 18 or over. To be considered, you should have been diagnosed with early to moderate open-angle glaucoma in at least one eye within the last 12 months. This includes common types of open-angle glaucoma. Importantly, your vision in at least one eye should be good enough (6/12 or better on an eye chart), and tests of your side vision (visual field) shouldn't show very severe damage.

There are also some conditions that would mean you couldn't take part. For example, if you have certain other eye conditions that affect your side vision beyond glaucoma, or if you've been diagnosed with most types of cancer in the last 5 years. If you're pregnant, planning to become pregnant, or breastfeeding, you also won't be able to join. Additionally, if you have severe kidney or liver problems, or are taking certain specific medications, you wouldn't be able to participate. Your study doctor will review all your health information carefully to see if this study is right for you.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with open-angle glaucoma in the last 12 months?
Is your vision in at least one eye generally good (6/12 or better)?
Are you able to attend appointments regularly for a few years?
Are you not pregnant, planning pregnancy, or breastfeeding?
Do you have certain medical conditions like severe liver/kidney issues or specific cancers in the last 5 years?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned by a computer to one of two groups: one group will receive Nicotinamide (NAM) tablets, and the other will receive a dummy pill (placebo). Neither you nor the study team will know which you are taking – this is called 'double-masked'. You will continue with your usual glaucoma eye drops or laser treatment. The study will involve several visits to the clinic over a period of time, probably lasting a couple of years or more. During these visits, you'll have eye tests, including checks of your vision and eye pressure, and special scans of your eye. You'll also have blood tests and regularly answer questions about your health. The study team will explain the exact schedule of visits and what each involves in detail before you make your decision.

Potential risks and benefits

Participating in this study might offer several potential benefits. You would receive cutting-edge care and close monitoring of your glaucoma, and you might personally benefit from Nicotinamide if it proves effective in slowing down vision loss. However, there's no guarantee that you will personally benefit from taking NAM, as it's still being investigated. Potential risks include possible side effects from the NAM tablets, though NAM is generally considered safe and well-tolerated at the doses being studied. As with any medication, individual reactions can vary. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Belfast City Hospital
Belfast, United Kingdom· Not yet recruiting
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom· Not yet recruiting
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, United Kingdom· Recruiting
Royal Liverpool Hospital
Liverpool, United Kingdom· Not yet recruiting
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom· Recruiting
Barnet Hospital, Royal Free London NHS Foundation Trust
London, United Kingdom· Not yet recruiting
King's College Hospital NHS Foundation Trust
London, United Kingdom· Recruiting
Manchester Royal Eye Hospital
Manchester, United Kingdom· Not yet recruiting
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom· Not yet recruiting
Queen Alexandra Hospital
Portsmouth, United Kingdom· Recruiting

Common questions

What is Nicotinamide?

Nicotinamide is a form of Vitamin B3. It's being studied here because it might help protect eye cells.

What is a 'placebo'?

A placebo is a 'dummy pill' that looks exactly like the study drug but contains no active medicine. It helps us fairly compare results.

Will I still use my regular glaucoma eye drops?

Yes, you will continue with your current glaucoma treatments (like eye drops or laser) as usual throughout the study.

How long will the study last for me?

The study will involve regular visits over a period of a couple of years or more, but the exact length will be explained by the study team.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and your usual medical care won't be affected.

How to find out more

NAMinG Trial Team

cctu.naming@ucl.ac.uk 0203 108 6148 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.