Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial) (NADIR)
2026년 9월 9일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
96
단계
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Steven C Quan, OD
- 전화번호: 773-702-1611
- 이메일: scquan@bsd.uchicago.edu
연구 연락처 백업
- 이름: Elza Rachid, MD
- 전화번호: 773-702-1611
- 이메일: Elza.Rachid@bsd.uchicago.edu
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago Medicine Duchossois Center for Advanced Medicine
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연락하다:
- Steven C Quan, OD
- 전화번호: 773-702-1611
- 이메일: scquan@bsd.uchicago.edu
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연락하다:
- Elza Rachid, MD
- 전화번호: 773-702-1611
- 이메일: Elza.Rachid@bsd.uchicago.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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.
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Annualized Rate of Macular Ganglion Cell-Inner Plexiform Layer (GCIPL) Thinning
기간: Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)
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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.
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Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Annualized Rate of Peripapillary Retinal Nerve Fiber Layer (RNFL) Thinning
기간: Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)
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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.
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Baseline (Month 0), Month 3, Month 6, and Month 12 (four repeated assessments over 12 months)
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Visual Field Mean Deviation Slope
기간: Baseline through Month 12, assessed at Baseline (Month 0), Month 3, Month 6, and Month 12
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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.
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Baseline through Month 12, assessed at Baseline (Month 0), Month 3, Month 6, and Month 12
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Incidence of Grade 2 or Higher Hepatic and Gastrointestinal Adverse Events
기간: From randomization through 30 days after the Month 12 visit (approximately 13 months)
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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.
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From randomization through 30 days after the Month 12 visit (approximately 13 months)
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Nicotinamide Adherence Rate
기간: Maintenance phase: Week 7 (Month 1 remote contact) through Month 12
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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.
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Maintenance phase: Week 7 (Month 1 remote contact) through Month 12
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Study Retention Rate
기간: Month 12 (52 weeks post-randomization)
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Proportion of randomized participants completing the Month 12 study visit with at least one valid post-baseline macular GCIPL measurement.
Assessed in both arms.
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Month 12 (52 weeks post-randomization)
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Macular Superficial Capillary Plexus Perfusion Density on OCT-A
기간: Baseline (Month 0) and Month 12 (pre- and post-intervention comparison)
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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.
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Baseline (Month 0) and Month 12 (pre- and post-intervention comparison)
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Change in Peripapillary Radial Capillary Plexus Perfusion Density on OCT-A
기간: Baseline (Month 0) and Month 12 (pre- and post-intervention comparison)
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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.
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Baseline (Month 0) and Month 12 (pre- and post-intervention comparison)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Steven C Quan, OD, University of Chicago
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2027년 6월 1일
기본 완료 (추정된)
기본 완료
2029년 9월 30일
연구 완료 (추정된)
연구 완료
2029년 10월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 9월 2일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 9월 2일
처음 게시됨 (실제)
처음 게시됨
2026년 9월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 11일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 9일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- IRB26-0972
- IND Number: 184022 (기타 식별자: U.S. Food and Drug Administration (FDA))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Beginning 12 months after primary study results publication
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .