Last updated: July 25, 2023
Sponsor: Umeå University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Glaucoma
Treatment
Nicotinamide
Placebo
Clinical Study ID
NCT05275738
TGNT
VBIGS
SGNT
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
SGNT: Inclusion Criteria:
- Adult participants (>18 years) with newly-diagnosed and previously untreated POAG orPEXG in one or both eyes. Glaucoma is defined as reproducible visual field (VF)defects that cannot be explained by other disease or damage, and a suspect/abnormaloptic nerve head and/or nerve fibre layer defect.
- Participants need to have visual acuity of Snellen ≥ 6/12 (0.5) or better.
- Have performed at least two reliable VFs (SITA-Fast 24-2), with <33% fixation lossesand <15% false positives
Exclusion
Exclusion Criteria:
- VF damage worse than -10dB in the best eye and -16dB in the worse eye or a paracentralspot with -10dB or less in any eye),
- IOP >35mmHg in any eye or a mean IOP of 30mmHg or higher (two measurements), •inability to perform VFs,
- pregnancy/breastfeeding,
- those unwilling to abstain from NAM supplements,
- allergic to NAM/niacin,
- diagnosed with cancer in the last 5 years (except treated basal or squamous cellcarcinoma),
- a history of liver disease or stomach ulcers,
- disease that prevents long-term follow-up,
- neurologic or other non-glaucomatous conditions apart from cataract that may affectthe VF, •inability to understand and speak Swedish or English,
- a history of intraocular surgery (apart from uncomplicated cataract surgery) and
- diseases that are known to affect retinal function (e.g. > mild age-related maculardegeneration, > stage I diabetic retinopathy). VBIGS: Inclusion Criteria:
- Patients aged 18 years or older, with definitive, treated POAG including normaltension glaucoma, PEXG in both eyes
- Best-corrected visual acuity ≥ 6/18
- Severity of visual field loss, MD between -3 and -18 dB. This range includes peoplewith moderate disease which optimises detection of progression.
- Patient must have performed at least two reliable VFs (24-2), with <33% fixationlosses and <15% false positives.
- Previous selective laser trabeculoplasty is acceptable (IOP-lowering laser treatment)if 3 or more months prior, and normal liver function tests.
- Those taking NAM already will undergo a 1-month washout period before commencing thestudy. Exclusion Criteria:
- Patients with a history of hepatic disease, gout, visually significant cataracts,other conditions that can affect VF results, cataract surgery in the last 3 months orglaucoma filtration surgery in last 6 months.
Study Design
Total Participants: 660
Treatment Group(s): 2
Primary Treatment: Nicotinamide
Phase:
Study Start date:
May 18, 2022
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
S:t Eriks Eye Hospital
Stockholm,
SwedenActive - Recruiting
Umeå University
Umeå,
SwedenActive - Recruiting
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