Glaucoma, Open-anglePhase 2NADIRNCT07808333
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
A Phase 2 study testing Nicotinamide and Standard Glaucoma Therapy in people with Glaucoma, Open-angle and Primary Open Angle Glaucoma (POAG), run by University of Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
- What is being tested?
- Nicotinamide and Standard Glaucoma Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 27 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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:
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Chicago Medicine Duchossois Center for Advanced Medicine
Chicago, Illinois, 60637
Steven C Quan, OD, 773-702-1611, scquan@bsd.uchicago.edu
Elza Rachid, MD, 773-702-1611, Elza.Rachid@bsd.uchicago.edu
About this study
Official title: 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.
Read the detailed description
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 an IND-regulated, prospective, randomized Phase 2a trial evaluating 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.
- Being tested
- Nicotinamide, Standard Glaucoma Therapy
- Keywords
- nicotinamide, NAD+, neuroprotection, retinal ganglion cells, GCIPL, optical coherence tomography, OCT-A, glaucoma progression, macular imaging, vitamin B3
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotinamideDrug
Also called Niacinamide, Vitamin B3, NAM, Rugby Niacinamide 500 mg
Immediate-release niacinamide (nicotinamide) 500 mg tablets (Rugby Laboratories, re-order no. 370739; manufactured by 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.
Standard Glaucoma TherapyOther
Individualized intraocular pressure-lowering therapy per the AAO Primary Open-Angle Glaucoma Preferred Practice Pattern, which may include topical IOP-lowering medications (e.g., prostaglandin analogs) 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.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Oral Nicotinamide Plus Standard Glaucoma Care | Experimental | 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. Receives: Drug: Nicotinamide; Other: Standard Glaucoma Therapy |
| Standard Glaucoma Care Alone (Active Control) | Active comparator | Participants receive individualized intraocular pressure-lowering therapy per the AAO Primary Open-Angle Glaucoma Preferred Practice Pattern, which may include topical IOP-lowering medications (e.g., 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. Receives: Other: Standard Glaucoma Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Rate of Macular Ganglion Cell-Inner Plexiform Layer (GCIPL) Thinning
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.
Measured: Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)
Secondary outcomes (5)
Annualized Rate of Peripapillary Retinal Nerve Fiber Layer (RNFL) Thinning
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.
Measured: Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)
Visual Field Mean Deviation Slope
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.
Measured: 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
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 NCI CTCAE v6.0. Hepatic laboratory values are assessed by comprehensive metabolic panel (CMP) at screening for all participants, and at Baseline, the Month 1 remote safety contact, and Months 3, 6, and 12 for Arm 1 participants. Adverse events are captured by symptom review and AE reporting in both arms.
Measured: From randomization through 30 days after the Month 12 visit (approximately 13 months)
Nicotinamide Adherence Rate
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.
Measured: Maintenance phase: Week 7 (Month 1 remote contact) through Month 12
Study Retention Rate
Proportion of randomized participants completing the Month 12 study visit with at least one valid post-baseline macular GCIPL measurement. Assessed in both arms.
Measured: Month 12 (52 weeks post-randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Jun 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion27 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-angleStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to two parallel arms using computer-generated permuted-block randomization with variable, concealed block sizes, stratified by glaucoma severity (mild: VF MD -2 to -6 dB vs. moderate: VF MD -6 to -12 dB) and race/ethnicity. Arm 1 receives high-dose oral nicotinamide plus standard glaucoma care; Arm 2 receives standard glaucoma care alone. Central SD-OCT, OCT-A, and visual field readers are masked to arm assignment and use de-identified participant IDs. There is no crossover between arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven C Quan, OD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808333
- Sponsor's protocol ID
- IRB26-0972
- Other IDs
- IND Number: 184022
- Acronym
- NADIR
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07808333
- Acronym / sponsor ID
- NADIR / IRB26-0972
- Keywords
- nicotinamide, NAD+, neuroprotection, retinal ganglion cells, GCIPL, optical coherence tomography, OCT-A, glaucoma progression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 27 Feb 2030 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 an IND-regulated, prospective, randomized Phase 2a trial evaluating 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to two parallel arms using computer-generated permuted-block randomization with variable, concealed block sizes, stratified by glaucoma severity (mild: VF MD -2 to -6 dB vs. moderate: VF MD -6 to -12 dB) and race/ethnicity. Arm 1 receives high-dose oral nicotinamide plus standard glaucoma care; Arm 2 receives standard glaucoma care alone. Central SD-OCT, OCT-A, and visual field readers are masked to arm assignment and use de-identified participant IDs. There is no crossover between arms.
| Arm | Type | Receives |
|---|---|---|
| High-Dose Oral Nicotinamide Plus Standard Glaucoma Care | Experimental | Drug: Nicotinamide, Other: Standard Glaucoma TherapyParticipants 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. |
| Standard Glaucoma Care Alone (Active Control) | Active comparator | Other: Standard Glaucoma TherapyParticipants receive individualized intraocular pressure-lowering therapy per the AAO Primary Open-Angle Glaucoma Preferred Practice Pattern, which may include topical IOP-lowering medications (e.g., 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotinamideAlso: Niacinamide, Vitamin B3, NAM, Rugby Niacinamide 500 mgImmediate-release niacinamide (nicotinamide) 500 mg tablets (Rugby Laboratories, re-order no. 370739; manufactured by 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. | Drug | High-Dose Oral Nicotinamide Plus Standard Glaucoma Care |
| Standard Glaucoma TherapyIndividualized intraocular pressure-lowering therapy per the AAO Primary Open-Angle Glaucoma Preferred Practice Pattern, which may include topical IOP-lowering medications (e.g., prostaglandin analogs) 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. | Other | High-Dose Oral Nicotinamide Plus Standard Glaucoma Care, Standard Glaucoma Care Alone (Active Control) |
Primary outcome
Annualized Rate of Macular Ganglion Cell-Inner Plexiform Layer (GCIPL) Thinning
Time frame: 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.
5 secondary outcomes
Annualized Rate of Peripapillary Retinal Nerve Fiber Layer (RNFL) Thinning
Time frame: Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)
Visual Field Mean Deviation Slope
Time frame: 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
Time frame: From randomization through 30 days after the Month 12 visit (approximately 13 months)
Nicotinamide Adherence Rate
Time frame: Maintenance phase: Week 7 (Month 1 remote contact) through Month 12
Study Retention Rate
Time frame: Month 12 (52 weeks post-randomization)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Glaucoma, Open-angle
Recruiting
A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Active, not recruiting
Electrical Stimulation for the Treatment of Optic Neuropathies
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven C Quan, OD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide and Standard Glaucoma Therapy in people with Glaucoma, Open-angle and Primary Open Angle Glaucoma (POAG), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven C Quan, OD (773-702-1611, scquan@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized Rate of Macular Ganglion Cell-Inner Plexiform Layer (GCIPL) Thinning (time frame: Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.