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Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial) (NADIR)

9. September 2026 aktualisiert von: University of Chicago

NADIR Trial: A Principal Investigator-Initiated, Single-Center, Open-Label, Active-Controlled Phase 2a Study of High-Dose Nicotinamide (Vitamin B3) Supplementation in Adults With Mild to Moderate Primary Open-Angle Glaucoma (POAG)

The goal of this clinical trial is to learn whether a high-dose vitamin B3 supplement called nicotinamide can protect retinal nerve cells in adults with primary open-angle glaucoma (POAG) who are already receiving standard glaucoma eye drops or laser treatment. The main question it aims to answer is: Does adding nicotinamide to standard glaucoma therapy slow the rate of thinning of the inner retinal nerve cell layer (measured by a non-invasive eye scan) compared to standard therapy alone over 12 months?

Participants will be randomly assigned to one of two groups. Participants in the treatment group will take nicotinamide tablets by mouth, starting at a lower dose (1.5 grams per day) for the first 6 weeks and increasing to the full dose (3.0 grams per day) for the remainder of the 12-month study. Participants in the control group will continue their standard glaucoma care without the supplement.

Researchers will compare retinal imaging measurements between the two groups to see whether nicotinamide reduces the rate of retinal nerve cell thinning over time.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Glaucoma causes progressive and irreversible loss of retinal ganglion cells (RGCs), often continuing despite adequate intraocular pressure control. Mitochondrial dysfunction and depletion of NAD+ (nicotinamide adenine dinucleotide) are increasingly recognized as central contributors to RGC vulnerability. Nicotinamide (NAM), a commercially available form of vitamin B3 and potent NAD+ precursor, has demonstrated robust neuroprotection in preclinical glaucoma models and early clinical trials outside the United States.

NADIR is the first IND-regulated, prospective, randomized Phase 2a trial in the United States to evaluate high-dose oral nicotinamide as adjunctive neuroprotective therapy in adults with mild to moderate POAG, using macular ganglion cell layer imaging (SD-OCT) as the primary structural biomarker detectable within 12 months. Ocular vascular perfusion imaging (OCT-A) is included as an exploratory endpoint.

Studientyp

Interventionell

Einschreibung (Geschätzt)

96

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Age 40 to 80 years, inclusive
  • Diagnosis of primary open-angle glaucoma (POAG) in at least one eye, confirmed by a licensed ophthalmologist or optometrist based on characteristic optic nerve head changes and/or visual field defects with an open anterior chamber angle
  • Mild to moderate glaucoma severity in the study eye: Humphrey Visual Field 24-2 mean deviation (MD) between -2.0 and -12.0 dB on at least one reliable test (fixation losses 33% or less, false positive rate 15% or less)
  • Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent) in the study eye
  • Confirmed glaucomatous structural damage on SD-OCT (average GCIPL and/or RNFL below age-adjusted normative mean on device-generated classification) and/or a reproducible visual field defect on Humphrey Visual Field 24-2 consistent with glaucoma, as confirmed by the enrolling glaucoma specialist at screening
  • Macular GCIPL and peripapillary RNFL above device-specific SD-OCT floor effect in the study eye
  • Currently receiving stable intraocular pressure-lowering therapy (topical medications and/or prior selective laser trabeculoplasty) for at least 4 months prior to enrollment, with no planned changes to glaucoma therapy at the time of enrollment
  • Intraocular pressure of 21 mmHg or less on current therapy at the screening visit in the study eye
  • Established patient receiving ongoing glaucoma care at University of Chicago Medicine Duchossois Center for Advanced Medicine Eye Clinic
  • Willing and able to provide written informed consent and comply with all study visit schedules and procedures
  • Study eye selection: when POAG is present bilaterally, the study eye is defined as the eye with more severe disease (worse VF MD) that meets all eligibility criteria; if both eyes are equivalent in severity, the right eye is designated by default

Exclusion Criteria:

  • Advanced glaucoma: visual field MD worse than -12.0 dB in the study eye
  • Significant retinal disease affecting macular structure or visual field, including advanced age-related macular degeneration, diabetic retinopathy greater than mild non-proliferative, clinically significant diabetic macular edema, major retinal vein occlusion, or non-glaucomatous optic neuropathy
  • Ocular surgery other than uncomplicated cataract extraction or selective laser trabeculoplasty within the past 6 months
  • Hepatic dysfunction at baseline: AST or ALT greater than 2 times the upper limit of normal, or total bilirubin greater than 1.5 times the upper limit of normal
  • Renal dysfunction: eGFR less than 30 mL/min/1.73 m2
  • Current use of, or unwillingness to abstain from:

nicotinamide, niacinamide, nicotinamide riboside (NR), nicotinamide mononucleotide (NMN), or any other NAD+-precursor supplement not dispensed by the study; high-dose niacin or vitamin B3; Ginkgo biloba; CoQ10; isoniazid; pyrazinamide; carbamazepine; phenobarbital; primidone; or sustained-release niacin or nicotinamide formulations

  • Poorly controlled diabetes mellitus: HbA1c greater than 9.0% at screening
  • Normal tension glaucoma with documented intraocular pressure consistently 21 mmHg or less without hypotensive therapy
  • Participation in another investigational drug trial within 30 days of screening
  • Pregnancy, lactation, or intent to become pregnant during the study period
  • Significant cognitive impairment or inability to comply with study requirements
  • Clinically significant media opacity (corneal, lenticular, or vitreal) sufficient to degrade OCT signal quality below device-minimum thresholds, even if BCVA of 20/40 or better is preserved
  • Active or recent uveitis or intraocular inflammation in the study eye within the past 3 months
  • Any condition that, in the investigator's judgment, would preclude safe participation or confound result interpretation

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: High-Dose Oral Nicotinamide Plus Standard Glaucoma Care
Participants receive immediate-release oral nicotinamide titrated from 1.5 g/day (500 mg three times daily with meals, Weeks 1 through 6) to 3.0 g/day (1,500 mg twice daily [three 500 mg tablets per administration, twice daily] with meals, Week 7 through Month 12), in addition to individualized standard glaucoma therapy. Dose advancement at Week 7 requires confirmation at the Month 1 remote safety contact that no Grade 2 or higher hepatic adverse event is present and gastrointestinal tolerability is acceptable.
Arzneimittel: Nicotinamide
Immediate-release nicotinamide 500 mg tablets (NDC 0-80681-01900; Rugby Laboratories / Contract Pharmacal Corp, Hauppauge NY). Titration phase: 500 mg three times daily (1.5 g/day total) for 6 weeks. Maintenance phase: 1,500 mg twice daily (three 500 mg tablets per administration, twice daily; 3.0 g/day total) from Week 7 through Month 12. Administered orally with meals. Dispensed and tracked by the University of Chicago Institutional Drug Service (IDS) Pharmacy under IND 184022.
Andere Namen:
  • Vitamin B3
  • Niacinamid
  • NAM
  • Rugby Niacinamide 500 mg
Sonstiges: Standard Glaucoma Therapy
Individualized intraocular pressure-lowering therapy per the 2026 American Academy of Ophthalmology Primary Open-Angle Glaucoma Preferred Practice Pattern. Includes topical prostaglandin analog eye drops and/or selective laser trabeculoplasty, with clinical monitoring by optical coherence tomography, standard automated perimetry, and intraocular pressure measurement at 3 to 6 month intervals based on disease status.
Aktiver Komparator: Standard Glaucoma Care Alone (Active Control)
Participants receive individualized standard glaucoma therapy per the 2026 American Academy of Ophthalmology Primary Open-Angle Glaucoma Preferred Practice Pattern, including intraocular pressure lowering with topical prostaglandin analogs and/or selective laser trabeculoplasty, with monitoring by optical coherence tomography, perimetry, and intraocular pressure measurement at 3 to 6 month intervals. No supplemental nicotinamide is administered.
Sonstiges: Standard Glaucoma Therapy
Individualized intraocular pressure-lowering therapy per the 2026 American Academy of Ophthalmology Primary Open-Angle Glaucoma Preferred Practice Pattern. Includes topical prostaglandin analog eye drops and/or selective laser trabeculoplasty, with clinical monitoring by optical coherence tomography, standard automated perimetry, and intraocular pressure measurement at 3 to 6 month intervals based on disease status.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Annualized Rate of Macular Ganglion Cell-Inner Plexiform Layer (GCIPL) Thinning
Zeitfenster: Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)
Rate of change in macular GCIPL thickness (micrometers per year) measured by spectral-domain optical coherence tomography (SD-OCT; Heidelberg Spectralis, minimum Q-score 20) with masked central image reading using de-identified participant IDs. The annualized thinning rate is estimated from repeated measurements using a linear mixed-effects model with random intercepts per participant and an arm-by-time interaction term as the primary inferential parameter.
Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Annualized Rate of Peripapillary Retinal Nerve Fiber Layer (RNFL) Thinning
Zeitfenster: Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)
Rate of change in average peripapillary RNFL thickness (micrometers per year) measured by SD-OCT (Heidelberg Spectralis) with masked central reading. Analyzed using the same linear mixed-effects model framework as the primary endpoint. Both average and quadrant-specific RNFL (superior, inferior, temporal, nasal) will be reported.
Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)
Visual Field Mean Deviation Slope
Zeitfenster: Baseline through Month 12, assessed at Baseline (Month 0), Month 3, Month 6, and Month 12
Rate of change in Humphrey Visual Field Analyzer 24-2 SITA Standard mean deviation (decibels per year), estimated as a continuous slope over 12 months using a linear mixed-effects model with random intercepts per participant. Assessed at four timepoints: Baseline, Month 3, Month 6, and Month 12.
Baseline through Month 12, assessed at Baseline (Month 0), Month 3, Month 6, and Month 12
Incidence of Grade 2 or Higher Hepatic and Gastrointestinal Adverse Events
Zeitfenster: From randomization through 30 days after the Month 12 visit (approximately 13 months)
Proportion of participants experiencing at least one hepatic adverse event (alanine aminotransferase or aspartate aminotransferase elevation, total bilirubin elevation) or gastrointestinal adverse event graded at Grade 2 or higher per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v6.0). Hepatic laboratory values assessed by comprehensive metabolic panel (CMP) at every study visit and at the Month 1 remote safety contact for all participants in both arms.
From randomization through 30 days after the Month 12 visit (approximately 13 months)
Nicotinamide Adherence Rate
Zeitfenster: Maintenance phase: Week 7 (Month 1 remote contact) through Month 12
Proportion of prescribed nicotinamide doses taken during the maintenance phase (Weeks 7 through 52), assessed by pill count and participant medication diary review at each in-person study visit. Applies to Arm 1 participants only.
Maintenance phase: Week 7 (Month 1 remote contact) through Month 12
Study Retention Rate
Zeitfenster: Month 12 (52 weeks post-randomization)
Proportion of randomized participants completing the Month 12 study visit with at least one valid post-baseline macular GCIPL measurement. Assessed in both arms.
Month 12 (52 weeks post-randomization)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Macular Superficial Capillary Plexus Perfusion Density on OCT-A
Zeitfenster: Baseline (Month 0) and Month 12 (pre- and post-intervention comparison)
Change from baseline in macular superficial capillary plexus perfusion density (percent) measured by optical coherence tomography angiography (OCT-A; Optovue Solix FullRange AngioVue, FDA 510(k) K222166; minimum signal strength index 30). Analyzed by ANCOVA with baseline perfusion density as covariate. Designated an exploratory endpoint in this Phase 2a trial; not a pre-specified confirmatory secondary outcome.
Baseline (Month 0) and Month 12 (pre- and post-intervention comparison)
Change in Peripapillary Radial Capillary Plexus Perfusion Density on OCT-A
Zeitfenster: Baseline (Month 0) and Month 12 (pre- and post-intervention comparison)
Change from baseline in peripapillary radial capillary plexus (RPC) perfusion density (percent) measured by optical coherence tomography angiography (OCT-A; Optovue Solix FullRange AngioVue, FDA 510(k) K222166; minimum signal strength index 30). Analyzed by ANCOVA with baseline peripapillary perfusion density as covariate and treatment arm as fixed factor. Macular and peripapillary perfusion density metrics are analyzed and reported separately. Designated an exploratory endpoint in this Phase 2a trial.
Baseline (Month 0) and Month 12 (pre- and post-intervention comparison)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Chicago

Ermittler

  • Hauptermittler: Steven C Quan, OD, University of Chicago

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2027

Primärer Abschluss (Geschätzt)

30. September 2029

Studienabschluss (Geschätzt)

31. Oktober 2029

Studienanmeldedaten

Zuerst eingereicht

2. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. September 2026

Zuerst gepostet (Tatsächlich)

8. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB26-0972
  • IND Number: 184022 (Andere Kennung: U.S. Food and Drug Administration (FDA))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data supporting primary and secondary outcome analyses will be made available following study completion and primary manuscript publication, subject to University of Chicago data governance policies and a data use agreement. Requests will be reviewed by the principal investigator.

IPD-Sharing-Zeitrahmen

Beginning 12 months after primary study results publication

IPD-Sharing-Zugriffskriterien

Requests submitted to the principal investigator with a brief description of the proposed analysis and intended use. De-identified data shared under a formal data use agreement per University of Chicago institutional policy.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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