Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078605
• Other study ID #: NRG1
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: CHA University
• Contact: Seungsoo Rho, MD, PhD
• Phone: 82-10-9260-3173
• Email: harryrho[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Not provided

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ganglion Cysts
• Glaucoma

Intervention

Other:
• Nicotinamide(Mitovita)
Nicotinamide(VitaminB3)
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	CHA University Bundang Medical Center	Seongnam	Bundang-gu

Sponsors (2)

Lead Sponsor	Collaborator
CHA University	Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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