Phase
Condition
Glaucoma
Treatment
Nicotinomide
Matching placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients who have been recently diagnosed (within the last 12 months) with early tomoderate open-angle glaucoma (OAG) in at least one eye (including primary OAG, normaltension 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 torandomisation 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 theduration of the trial
Exclusion
Exclusion Criteria:
- Pigment dispersion glaucoma
- Pregnancy (or planned pregnancy during the trial) and/or breastfeeding
- Women of childbearing potential and male participants with a partner of childbearingpotential not willing to use highly effective contraception for the duration of thetrial treatment and for the time period specified following last trial treatmentadministration.
- Current treatment with either isoniazid, pyrazinamide, carbamazepine, phenobarbital orprimidone
- Current liver disease or laboratory results with elevated levels of livertransaminases (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 toblepharochalasis)
- Diagnosed with cancer in the last 5 years (with exception of non-melanoma skincancer).
- Any clinical condition that, in the investigator's opinion would make the participantunsuitable for the trial.
- Concurrently enrolled in any other interventional trial or participation in previousclinical trial of glaucoma.
- Current use of, and unwilling to abstain from, over-the-counter additional vitaminB3/NAM oral supplements (including skin preparations such as ointments/emulsions),Ginkgo Biloba and/or Coenzyme Q10 supplements, throughout the duration of theirparticipation in the trial.
Study Design
Study Description
Connect with a study center
Belfast City Hospital
Belfast, Northern Ireland BT9 7AB
United KingdomSite Not Available
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 OQQ
United KingdomSite Not Available
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, RH19 3DZ
United KingdomActive - Recruiting
Royal Liverpool Hospital
Liverpool, L7 8XP
United KingdomSite Not Available
Barnet Hospital, Royal Free London NHS Foundation Trust
London, EN5 3DJ
United KingdomSite Not Available
King's College Hospital NHS Foundation Trust
London, SE5 9RS
United KingdomActive - Recruiting
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
United KingdomActive - Recruiting
Royal Free London NHS Foundation Trust
London, NW3 2QG
United KingdomSite Not Available
Manchester Royal Eye Hospital
Manchester, M13 9WL
United KingdomSite Not Available
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY
United KingdomSite Not Available
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
United KingdomSite Not Available
Queen Alexandra Hospital
Portsmouth, PO6 3LY
United KingdomActive - Recruiting
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