Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

NCT06078605 | Unknown

• 1 other identifier: NRG1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Glaucoma

Keywords

Nicotinamide; inner retinal function; retinal ganglion cell functions; Glaucoma; Vitamin B3; NAM; NRG1

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline,12weeks

Secondary Outcomes (6)

• Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)

  Baseline, 6, 12, 18, 24weeks

• Change of PhNR_min(photopic negative response) as measured by Electroretinogram (Group1 VS Group2)

  Baseline, 6, 12, 18, 24weeks

• Change of mean deviation as measured by Visual Fields (intra-group)

  Baseline, 12weeks, 24weeks

• Change of mean deviation as measured by Visual Fields (Group1 VS Group2)

  Baseline, 12weeks, 24weeks

• Change of Pointwise sensitivity as measured by Visual Fields (Group1 VS Group2)

  Baseline, 12weeks, 24weeks

Study Arms (2)

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)

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)

Other: Placebo

Interventions

Nicotinamide(Mitovita) OTHER

Nicotinamide(VitaminB3)

Nicotinamide(Mitovita)

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• CHA University: lead
• Hanlim Pharm. Co., Ltd.: collaborator

Study Sites (1)

CHA University Bundang Medical Center

Seongnam, Bundang-gu, 13497, South Korea

RECRUITING

Related Publications (1)

• 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. 2025 Oct 30:bjo-2025-328096. doi: 10.1136/bjo-2025-328096. Online ahead of print.

  PMID: 41167798 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Seungsoo Rho, MD, PhD

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seungsoo Rho, MD, PhD

CONTACT

82-10-9260-3173; harryrho@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: October 12, 2023
• Study Start: September 16, 2022
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

KR (1)