Status:
RECRUITING
Nicotinamide in Glaucoma (NAMinG): A Randomised, Placebo-controlled, Multi-centre, Phase III Trial
Lead Sponsor:
University College, London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Glaucoma, Open-Angle
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 following last trial treatment administration.
- 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 interventional 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, throughout the duration of their participation in the trial.
Key Trial Info
Start Date :
January 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT05405868
Start Date
January 18 2024
End Date
June 30 2027
Last Update
May 9 2024
Active Locations (10)
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1
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom, BT9 7AB
2
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 OQQ
3
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, United Kingdom, RH19 3DZ
4
Royal Liverpool Hospital
Liverpool, United Kingdom, L7 8XP