Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

Sponsor

CHA University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06078605

Collaborator

Hanlim Pharm. Co., Ltd. (Industry)

Enrollment

Location

Arms

21.5

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Other: Nicotinamide(Mitovita) Other: Placebo	N/A

Detailed Description

Not provided

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 16, 2022

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Other: Nicotinamide(Mitovita) Nicotinamide(VitaminB3)
Placebo Comparator: Placebo 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 Placebo

Arm

Intervention/Treatment

Experimental: 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)

Other: Nicotinamide(Mitovita)

Nicotinamide(VitaminB3)

Placebo Comparator: Placebo

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

Placebo

Outcome Measures

Primary Outcome Measures

Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group) [Baseline,12weeks]
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 12 weeks

Secondary Outcome Measures

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 after 6, 12, 18 and 24 weeks
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (Group1 VS Group2) [Baseline, 6, 12, 18, 24weeks]
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks
Change of mean deviation as measured by Visual Fields (intra-group) [Baseline, 12weeks, 24weeks]
Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks
Change of mean deviation as measured by Visual Fields (Group1 VS Group2) [Baseline, 12weeks, 24weeks]
Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks
Change of Pointwise sensitivity as measured by Visual Fields (Group1 VS Group2) [Baseline, 12weeks, 24weeks]
Change of Pointwise sensitivity in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total/pattern deviation
Change of visual field sensitivity number of locations [Baseline, 12weeks, 24weeks]
Change of visual field sensitivity number of locations in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total, pattern deviation

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.