Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Other: Nicotinamide(Mitovita); Other: Placebo

• Registration Number: NCT06078605
• Lead Sponsor: CHA University

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

Detailed Description

Not provided

Study Timeline

• Study Start: 2022-09-16
• Study First Submitted: 2023-02-13
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Adult(Male or Female) over 19 years who were diagnosed with glaucoma.
2. In the case of participants receiving glaucoma treatment drugs, the investigator judges that the intraocular pressure remains constant for at least 1 year.
3. Intraocular pressure (IOP) >/= 8mmHg and < 18mmHg in each eye using Goldmann applanation tonometry prior to the screening visit
4. Adult participants diagnosed and treated for early-moderate glaucoma (VF mean deviation(MD) ≥-12 dB)
5. Have performed a reliable visual field in the last year, with <33% fixation losses, false positives and false negatives.
6. Written consent voluntarily to participate in this clinical trial.

Exclusion Criteria

1. Patients with congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
2. BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
3. Patients who have medical history of ocular inflammation
4. 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.)
5. Patients who have plans to intraocular surgery within the clinical trial period.
6. Patients with a history of significant ocular trauma within 6 months prior to the screening visit
7. Pregnant or lactating women.
8. A person who disagrees to contraception during a clinical trial period.
9. Patients with a history of malignancy within 5 years prior to the screening visit.
10. Patients that other researchers are determined inadequately.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotinamide(Mitovita)	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	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
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 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 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

Trial Locations

Locations (1)

CHA University Bundang Medical Center; 🇰🇷 Seongnam, Bundang-gu, Korea, Republic of