Testing Nicotinamide for Improving Eye Function in Glaucoma Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: harryrho@gmail.com
• Phone: 82-10-9260-3173

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Long-Term Results After Ab-interno Trabeculotomy for Glaucoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.