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New treatment option for Glaucoma, Open-Angle
Official title Nicotinamide in Glaucoma (NAMinG): A Randomised, Placebo-controlled, Multi-centre, Phase III Trial
ClinicalTrials.gov ID: NCT05405868
What this study is testing
What is Nicotinomide?
Nicotinomide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for glaucoma, open-angle.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Pigment dispersion glaucoma
- Pregnancy (or planned pregnancy during the trial) and/or breastfeeding
- Women of childbearing potential and male participants with a partner of childbearing potential not willing to use highly effective contraception for...
- Current treatment with either isoniazid, pyrazinamide, carbamazepine, phenobarbital or primidone
- Current liver disease or laboratory results with elevated levels of liver transaminases (AST or ALT \>3 x ULN) at screening visit.
- Renal failure (eGFR \<30mL/min/1.73m²) at screening visit.
See the full eligibility criteria
- 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...
- 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
- Pigment dispersion glaucoma
- Pregnancy (or planned pregnancy during the trial) and/or breastfeeding
- 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...
- Current treatment with either isoniazid, pyrazinamide, carbamazepine, phenobarbital or primidone
- Current liver disease or laboratory results with elevated levels of liver transaminases (AST or ALT \>3 x ULN) at screening visit.
- Renal failure (eGFR \<30mL/min/1.73m²) at screening visit.
- Conditions affecting both eyes which may affect the Visual Field test result:
- Diabetic retinopathy or any other retinal disease causing VF loss
- Clinically relevant cataract (likely to require cataract surgery within the next 2 years)
- Dementia or other non-glaucomatous neurological disease causing VF loss
- Adnexal conditions causing VF loss (including but not limited to blepharochalasis)
- Diagnosed with cancer in the last 5 years (with exception of non-melanoma skin cancer).
- Any clinical condition that, in the investigator's opinion would make the participant unsuitable for the trial.
- Concurrently enrolled in any other treatment trial or participation in previous clinical trial of glaucoma.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Belfast, Northern Ireland, United Kingdom
- Cambridge, United Kingdom
- East Grinstead, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Nottingham, United Kingdom
- Portsmouth, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belfast, Northern Ireland, United Kingdom; Cambridge, United Kingdom; East Grinstead, United Kingdom; Liverpool, United Kingdom; London, United Kingdom; Manchester, United Kingdom and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.