Status:
RECRUITING
The Glaucoma Nicotinamide Trial
Lead Sponsor:
Umeå University
Collaborating Sponsors:
Center for Eye Research Australia
Karolinska Institutet
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Glaucoma Nicotinamide Trial (TGNT) is a prospective, randomized, placebo-controlled double-masked clinical trial composed of two cohorts; The Swedish Glaucoma Nicotinamide Trial (SGNT) and the Vit...
Detailed Description
The treatment arms that included patients will be randomized into are either Nicotinamide tablets 1.5g for 6 weeks and then 3.0g onwards or true placebo tablets. A major difference between the SGNT an...
Eligibility Criteria
Inclusion
- SGNT:
- Adult participants (\>18 years) with newly-diagnosed and previously untreated POAG or PEXG 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/abnormal optic 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 losses and \<15% false positives
Exclusion
- VF damage worse than -10dB in the best eye and -16dB in the worse eye or a paracentral spot 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 cell carcinoma),
- 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 affect the 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 macular degeneration, \> stage I diabetic retinopathy).
- VBIGS:
- Inclusion Criteria:
- Patients aged 18 years or older, with definitive, treated POAG including normal tension 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 people with moderate disease which optimises detection of progression.
- Patient must have performed at least two reliable VFs (24-2), with \<33% fixation losses 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 the study.
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT05275738
Start Date
May 18 2022
End Date
December 31 2026
Last Update
July 27 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
S:t Eriks Eye Hospital
Stockholm, Sweden
2
Umeå University
Umeå, Sweden