NCT06731582

Brief Summary

The goal of this clinical trial is to learn if nicotinamide (NAM, vitamin B3) supplementation can delay glaucoma progression 30% above that achieved with conventional glaucoma treatment using topical medication. The main questions it aims to answer are: Can NAM supplementation improve the visual function of patients with glaucoma measured by visual field perimetry? Researchers will compare NAM to a placebo (a look-alike substance that contains no drug) to see if NAM works as an adjuvant in glaucoma treatment. Participants will:

  • Take NAM or a placebo every day for 2 years
  • Visit the clinic once every 3-4 months for checkups and tests

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_3

Timeline
26mo left

Started Mar 2024

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Mar 2024Jul 2028

Study Start

First participant enrolled

March 12, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

3.3 years

First QC Date

December 9, 2024

Last Update Submit

December 9, 2024

Conditions

Glaucoma

Keywords

nicotinamidevitamin B3NAM

Outcome Measures

Primary Outcomes (1)

  • Mean Deviation (MD)

    ≥ 30% reduction in visual field mean deviation progression measured over 2 years compared to current IOP-lowering treatments alone.

    2 years

Study Arms (2)

Nicotinamide

EXPERIMENTAL

1.5 grams/day (2 tablets of 750 mg each)

Dietary Supplement: Nicotinamide Tablet

Placebo

PLACEBO COMPARATOR

2 tablets

Dietary Supplement: Nicotinamide Placebo

Interventions

Nicotinamide TabletDIETARY_SUPPLEMENT

1.5 grams/day

Nicotinamide
Nicotinamide PlaceboDIETARY_SUPPLEMENT

2 tablets

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ³ 21 years, with definitive, treated POAG, PACG including normal tension glaucoma, PDG, PXFG in one or both eyes.
  • Best-corrected visual acuity equal or better than 6/18
  • Reproducible visual field defect due to glaucoma (3 contiguous points at less than 5%) and severity of visual field loss, MD between -2 and -18 dB. This range includes people with moderate disease which optimises detection of progression.
  • Patients must have at least two prior 24-2 VF tests which meet \<16% FP and \<21% fixation loss.
  • Previous selective laser trabeculoplasty is acceptable (IOP-lowering laser treatment) if ³ 3 months prior or filtering surgery \>6 months previously.
  • Normal liver function tests.
  • Those taking NAM already will undergo a 1-month washout period bef

You may not qualify if:

  • Patients with active liver disease or end stage renal failure.
  • Active use of allopurinol, carbamazepine, or primidone.
  • Visually significant cataracts (example, likely to require surgery within 2 years).
  • Cataract surgery in the last 3 months or glaucoma filtration surgery in last 6 months.
  • Conditions that may cause non-glaucomatous visual field defect (for example, severe ptosis, cerebrovascular accident, prior panretinal photocoagulation, and other retinal or central nervous system diseases).
  • Not able to complete study (for example, concurrent severe systemic disease).
  • History of cancer in the last 5 years.
  • Unable to give consent.
  • Inability to tolerate or take nicotinamide and/or pyruvate.
  • Women of Child Bearing Potential, pregnancy or lactation.
  • History of Hypotension
  • Blood Pressure measurement of less than 90/60(

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University Hospital

Singapore, Central Singapore, 119074, Singapore

Location

Singapore Eye Research Institute

Singapore, Central Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 12, 2024

Study Start

March 12, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations

SG(2)