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Trial Title:
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients
NCT ID:
NCT06078605
Condition:
Glaucoma
Conditions: Official terms:
Ganglion Cysts
Glaucoma
Niacinamide
Niacin
Nicotinic Acids
Conditions: Keywords:
Nicotinamide
inner retinal function
retinal ganglion cell functions
Glaucoma
Vitamin B3
NAM
NRG1
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Other
Intervention name:
Nicotinamide(Mitovita)
Description:
Nicotinamide(VitaminB3)
Arm group label:
Nicotinamide(Mitovita)
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Placebo
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
Criteria for 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.
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHA University Bundang Medical Center
Address:
City:
Seongnam
Zip:
13497
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seungsoo Rho, MD, PhD
Phone:
+82-10-9260-3173
Email:
harryrho@gmail.com
Start date:
September 16, 2022
Completion date:
June 30, 2024
Lead sponsor:
Agency:
CHA University
Agency class:
Other
Collaborator:
Agency:
Hanlim Pharm. Co., Ltd.
Agency class:
Industry
Source:
CHA University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06078605
