Testing Nicotinamide for Improving Eye Function in Glaucoma Patients

Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study

This study is testing if Nicotinamide, a type of Vitamin B3, can help improve eye function in people with glaucoma.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: CHA University (other)
• Locations: 1 site (Seongnam, Bundang-gu)
• Trial ID: NCT06078605 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of Nicotinamide, a form of Vitamin B3, on the functions of retinal ganglion cells in patients diagnosed with glaucoma. It employs a randomized, double-blind, placebo-controlled, cross-over design to ensure robust results. Participants will receive either Nicotinamide or a placebo, with the aim of assessing improvements in inner retinal function. The study is conducted at a single center, CHA University Bundang Medical Center.

Who should consider this trial

Good fit: Ideal candidates are adults over 19 years old diagnosed with early to moderate glaucoma and stable intraocular pressure.

Not a fit: Patients with congenital or secondary glaucoma, significant visual acuity loss, or a history of ocular inflammation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance retinal function and potentially slow the progression of glaucoma in affected patients.

How similar studies have performed: While the use of Nicotinamide in this context is relatively novel, previous studies have indicated potential benefits of Vitamin B3 in retinal health.

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.

Where this trial is running

Seongnam, Bundang-gu

• CHA University Bundang Medical Center — Seongnam, Bundang-gu, Korea, Republic of (RECRUITING)

Study contacts

• Principal investigator: Seungsoo Rho, MD, PhD — CHA Bundang Medical Center
• Study coordinator: Seungsoo Rho, MD, PhD

Conditions: Glaucoma, Nicotinamide, inner retinal function, retinal ganglion cell functions, Vitamin B3, NAM, NRG1