Clinical trial NCT06078605: Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Keywords: Nicotinamide
inner retinal function
retinal ganglion cell functions
Glaucoma
Vitamin B3
NAM
NRG1
Lead sponsor: CHA University
Sponsor class: OTHER
Collaborators: name: Hanlim Pharm. Co., Ltd.
First posted: 2023-10-12
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
timeFrame: Baseline,12weeks
Secondary outcomes:
measure: Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
timeFrame: Baseline, 6, 12, 18, 24weeks
measure: Change of PhNR_min(photopic negative response) as measured by Electroretinogram (Group1 VS Group2)
timeFrame: Baseline, 6, 12, 18, 24weeks
measure: Change of mean deviation as measured by Visual Fields (intra-group)
timeFrame: Baseline, 12weeks, 24weeks
measure: Change of mean deviation as measured by Visual Fields (Group1 VS Group2)
timeFrame: Baseline, 12weeks, 24weeks
measure: Change of Pointwise sensitivity as measured by Visual Fields (Group1 VS Group2)
timeFrame: Baseline, 12weeks, 24weeks
measure: Change of visual field sensitivity number of locations
timeFrame: Baseline, 12weeks, 24weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA University Bundang Medical Center
state: Bundang-gu
Study officials:
affiliation: CHA Bundang Medical Center
name: Seungsoo Rho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: