NAMinGA 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
Nicotinomide
+ Matching placebo
Eye Diseases+1
+ Glaucoma
+ Glaucoma, Open-Angle
Treatment Study
Summary
Study start date: January 18, 2024
Actual date on which the first participant was enrolled.Open Angle Glaucoma (OAG) is a chronic optic neuropathy causing progressive vision loss. It is well established that IOP is the only currently modifiable risk factor for glaucoma progression, and it is widely accepted that other risk factors modulate the susceptibility of an eye to IOP. This has led to a considerable body of research into neurodegenerative mechanisms and potential neuroprotective approaches. Various pathways contributing to the neurodegeneration have been implicated, and many have focussed on the role of mitochondria. Neuroprotection would significantly reduce sight loss and the burden of IOP-lowering eye drop treatment needed for disease control. There is evidence that susceptibility to IOP is related to mitochondrial function and ageing is associated with mitochondrial functional decline. The knowledge gap addressed in this trial is the relative contribution that mitochondrial function makes to glaucomatous neurodegeneration and whether boosting mitochondrial function with NAM slows progression in humans in the same way that it does in animal models. Biomarkers for mitochondrial-related susceptibility have not yet been established in humans. The proposal therefore is a new mechanism neuroprotection to improve resistance to eye pressure and evaluate the long-term safety and efficacy of NAM to preserve vision and its mechanism of action. There is strong evidence that mitochondrial dysfunction is associated with OAG susceptibility and that NAM improves mitochondrial function. Research has shown short-term vision improvement with high-dose NAM in glaucoma patients. NAM is safe and well-tolerated.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.496 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. 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) 2. Open angle on gonioscopy 3. Adults aged 18 years or over 4. Snellen visual acuity 6/12 or better in at least one eye meeting the visual field (VF) criteria 5. Visual Field (VF) mean deviation (MD) no worse than -12dB in either eye 6. A negative pregnancy test result at the screening and baseline visit prior to randomisation for women of childbearing potential 7. Ability to provide informed consent to participate 8. Able and willing to attend trial visits and comply with trial procedures for the duration of the trial Exclusion Criteria: 1. Pigment dispersion glaucoma 2. Pregnancy (or planned pregnancy during the trial) and/or breastfeeding 3. 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 primidone 5. 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 visit. 7. Conditions affecting both eyes which may affect the Visual Field test result: 1. Diabetic retinopathy or any other retinal disease causing VF loss 2. Clinically relevant cataract (likely to require cataract surgery within the next 2 years) 3. Dementia or other non-glaucomatous neurological disease causing VF loss 4. 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 trial. 10. Concurrently enrolled in any other interventional trial or participation in previous clinical trial of glaucoma. 11. 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, United KingdomOpen Queen Victoria Hospital NHS Foundation Trust in Google MapsMoorfields Eye Hospital NHS Foundation Trust
London, United KingdomKing's College Hospital NHS Foundation Trust
London, United KingdomQueen Alexandra Hospital
Portsmouth, United Kingdom