GlaucomaNCT06078605
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients
A study testing Nicotinamide(Mitovita) in people with Glaucoma, run by CHA University at 1 site in South Korea.
Trial summary
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Nicotinamide(Mitovita)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Sep 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult(Male or Female) over 19 years who were diagnosed with glaucoma.
- In the case of participants receiving glaucoma treatment drugs, the investigator judges that the intraocular pressure remains constant for at least 1 year.
- Intraocular pressure (IOP) >/= 8mmHg and < 18mmHg in each eye using Goldmann applanation tonometry prior to the screening visit
- Adult participants diagnosed and treated for early-moderate glaucoma (VF mean deviation(MD) ≥-12 dB)
- Have performed a reliable visual field in the last year, with <33% fixation losses, false positives and false negatives.
- Written consent voluntarily to participate in this clinical trial.
Who cannot join
- Patients with congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
- BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
- Patients who have medical history of ocular inflammation
- Patients with any ocular/systemic conditions that may affect electroretinogram parameter, or with visual field defects(Ischemic optic neuropathy, Proliferative diabetic retinopathy, Macular degeneration etc.)
- Patients who have plans to intraocular surgery within the clinical trial period.
- Patients with a history of significant ocular trauma within 6 months prior to the screening visit
Show all 10Show fewer
- Pregnant or lactating women.
- A person who disagrees to contraception during a clinical trial period.
- Patients with a history of malignancy within 5 years prior to the screening visit.
- Patients that other researchers are determined inadequately.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
CHA University Bundang Medical Center
Seongnam, Bundang-gu, 13497
Seungsoo Rho, MD, PhD, +82-10-9260-3173, harryrho@gmail.com
About this study
Official title: Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study
Read the detailed description
Not provided
- Conditions
- Glaucoma
- Being tested
- Nicotinamide(Mitovita), Placebo
- Keywords
- Nicotinamide, inner retinal function, retinal ganglion cell functions, Glaucoma, Vitamin B3, NAM, NRG1
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide(Mitovita)Other
Nicotinamide(VitaminB3)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide(Mitovita) | Experimental | Group2 Baseline-6week: (Mitovita: 1.0 g/day, QD) 6-12week: (Mitovita: 2.0 g/day, BID) Crossover 12-18week: (Placebo: 1.0 g/day, QD) 18-24week: (Placebo: 2.0 g/day, BID) Receives: Other: Nicotinamide(Mitovita) |
| Placebo | Placebo comparator | Group1 Baseline-6week: (Placebo: 1.0 g/day, QD) 6-12week: (Placebo: 2.0 g/day, BID) Crossover 12-18week: (Mitovita: 1.0 g/day, QD) 18-24week: (Mitovita: 2.0 g/day, BID) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 12 weeks
Measured: Baseline,12weeks
Secondary outcomes (6)
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks
Measured: Baseline, 6, 12, 18, 24weeks
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (Group1 VS Group2)
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks
Measured: Baseline, 6, 12, 18, 24weeks
Change of mean deviation as measured by Visual Fields (intra-group)
Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks
Measured: Baseline, 12weeks, 24weeks
Change of mean deviation as measured by Visual Fields (Group1 VS Group2)
Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks
Measured: Baseline, 12weeks, 24weeks
Change of Pointwise sensitivity as measured by Visual Fields (Group1 VS Group2)
Change of Pointwise sensitivity in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total/pattern deviation
Measured: Baseline, 12weeks, 24weeks
Change of visual field sensitivity number of locations
Change of visual field sensitivity number of locations in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total, pattern deviation
Measured: Baseline, 12weeks, 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start16 Sep 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Seungsoo Rho, MD, PhD, Principal investigator, CHA Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078605
- Sponsor's protocol ID
- NRG1
- Status last verified
- Oct 2023
- First submitted
- 13 Feb 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ha A, Kim YK, Lee CK, Williams PA, Morgan JE, Shin YI, Kim E, Kim M, Rho S. Effects of nicotinamide supplementation in normal-tension glaucoma: a crossover placebo-controlled randomised clinical trial. Br J Ophthalmol. 2026 Mar 20;110(4):417-424. doi: 10.1136/bjo-2025-328096.
PubMed 41167798
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study
- ClinicalTrials.gov ID
- NCT06078605
- Acronym / sponsor ID
- NRG1
- Conditions
- Glaucoma
- Keywords
- Nicotinamide, inner retinal function, retinal ganglion cell functions, Glaucoma, Vitamin B3, NAM, NRG1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Oct 2023 (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.
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study
Detailed description
Not provided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide(Mitovita) | Experimental | Other: Nicotinamide(Mitovita)Group2 Baseline-6week: (Mitovita: 1.0 g/day, QD) 6-12week: (Mitovita: 2.0 g/day, BID) Crossover 12-18week: (Placebo: 1.0 g/day, QD) 18-24week: (Placebo: 2.0 g/day, BID) |
| Placebo | Placebo comparator | Other: PlaceboGroup1 Baseline-6week: (Placebo: 1.0 g/day, QD) 6-12week: (Placebo: 2.0 g/day, BID) Crossover 12-18week: (Mitovita: 1.0 g/day, QD) 18-24week: (Mitovita: 2.0 g/day, BID) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult(Male or Female) over 19 years who were diagnosed with glaucoma.
- In the case of participants receiving glaucoma treatment drugs, the investigator judges that the intraocular pressure remains constant for at least 1 year.
- Intraocular pressure (IOP) >/= 8mmHg and < 18mmHg in each eye using Goldmann applanation tonometry prior to the screening visit
- Adult participants diagnosed and treated for early-moderate glaucoma (VF mean deviation(MD) ≥-12 dB)
- Have performed a reliable visual field in the last year, with <33% fixation losses, false positives and false negatives.
Key exclusion criteria (10 listed)
- Patients with congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
- BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
- Patients who have medical history of ocular inflammation
- Patients with any ocular/systemic conditions that may affect electroretinogram parameter, or with visual field defects(Ischemic optic neuropathy, Proliferative diabetic retinopathy, Macular degeneration etc.)
- Patients who have plans to intraocular surgery within the clinical trial period.
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 |
|---|---|---|
| Nicotinamide(Mitovita)Nicotinamide(VitaminB3) | Other | Nicotinamide(Mitovita) |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
Time frame: Baseline,12weeks
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 12 weeks
6 secondary outcomes
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
Time frame: Baseline, 6, 12, 18, 24weeks
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (Group1 VS Group2)
Time frame: Baseline, 6, 12, 18, 24weeks
Change of mean deviation as measured by Visual Fields (intra-group)
Time frame: Baseline, 12weeks, 24weeks
Change of mean deviation as measured by Visual Fields (Group1 VS Group2)
Time frame: Baseline, 12weeks, 24weeks
Change of Pointwise sensitivity as measured by Visual Fields (Group1 VS Group2)
Time frame: Baseline, 12weeks, 24weeks
Change of visual field sensitivity number of locations
Time frame: Baseline, 12weeks, 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 41167798Ha A, Kim YK, Lee CK, Williams PA, Morgan JE, Shin YI, Kim E, Kim M, Rho S. Effects of nicotinamide supplementation in normal-tension glaucoma: a crossover placebo-controlled randomised clinical trial. Br J Ophthalmol. 2026 Mar 20;110(4):417-424. doi: 10.1136/bjo-2025-328096.
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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. This study is not recruiting at the moment.
Seungsoo Rho, MD, PhD principal investigator
CHA Bundang Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide(Mitovita) in people with Glaucoma, run by CHA University at 1 site in South Korea.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seungsoo Rho, MD, PhD (82-10-9260-3173, harryrho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group) (time frame: Baseline,12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06078605, which also lists 1 linked publication.
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 12 Oct 2023.