NCT06731582Enrolling by invitationPhase 3
Nicotinamide Supplementation in Glaucoma
Targeting Metabolic Insufficiency (TAMING) Glaucoma Study : a 2-year Multi-centre, Double-masked, Randomised, Placebo-controlled Trial of Nicotinamide (Vitamin B3) Supplementation in Glaucoma
Source: ClinicalTrials.gov · Last updated 12 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 520 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- 12 Mar 2024
- Primary completion date
- Jul 2027
- Lead sponsor
- Singapore Eye Research Institute
- Diseases
- Glaucoma
- NCT number
- NCT06731582
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 520
- From 12 Mar 2024 to the primary completion date, Jul 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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(
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Singapore Eye Research Institute Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.