Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

Study Overview
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Brief Summary
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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
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Not provided

Official Title
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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
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Glaucoma

Intervention / Treatment
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* Other: Nicotinamide(Mitovita)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotinamide(Mitovita)<br>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)<br>* Nicotinamide(VitaminB3)<br>|
| Placebo Comparator: Placebo<br>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<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | Baseline, 12weeks, 24weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAM, Nicotinamide, inner retinal function, retinal ganglion cell functions, Glaucoma, Vitamin B3, NRG1