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RecruitingNCT06078605Updated Oct 12, 2023

Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

An interventional study of Nicotinamide(Mitovita) and Placebo in Glaucoma, sponsored by CHA University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-10-12.

Sponsored by CHA University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Sep 2022, registered Feb 2023).
  • Started Sep 2022; still recruiting 4 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

Read the detailed description

Not provided

02

Conditions studied

  • Glaucoma

Keywords

  • Nicotinamide
  • inner retinal function
  • retinal ganglion cell functions
  • Glaucoma
  • Vitamin B3
  • NAM
  • NRG1
03

In context

Ganglion Cysts

136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 101 interventional studies indexed under Ganglion Cysts.

Browse Ganglion Cysts studies →

Lead sponsor

CHA University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Nicotinamide(Mitovita)

    Group2 Baseline-6week: (Mitovita: 1.0 g/day, QD) 6-12week: (Mitovita: 2.0 g/day, BID) Crossover 12-18week: (Placebo: 1.0 g/day, QD) 18-24week: (Placebo: 2.0 g/day, BID)

    Other: Nicotinamide(Mitovita)

  • Placebo comparator
    Placebo

    Group1 Baseline-6week: (Placebo: 1.0 g/day, QD) 6-12week: (Placebo: 2.0 g/day, BID) Crossover 12-18week: (Mitovita: 1.0 g/day, QD) 18-24week: (Mitovita: 2.0 g/day, BID)

    Other: Placebo

Interventions

  • OtherNicotinamide(Mitovita)

    Nicotinamide(VitaminB3)

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline,12weeks

Secondary outcomes

  1. 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

    Time frame: Baseline, 6, 12, 18, 24weeks

  2. 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

    Time frame: Baseline, 6, 12, 18, 24weeks

  3. 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

    Time frame: Baseline, 12weeks, 24weeks

  4. 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

    Time frame: Baseline, 12weeks, 24weeks

  5. 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

    Time frame: Baseline, 12weeks, 24weeks

  6. 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

    Time frame: Baseline, 12weeks, 24weeks

07

Study locations

1 of 1 sites recruiting
  • CHA University Bundang Medical Center
    Seongnam, Bundang-gu 13497, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06078605
Lead sponsor
CHA University
Collaborators
Hanlim Pharm. Co., Ltd.
Responsible party
Sponsor
First posted
Oct 12, 2023
Start date
Sep 16, 2022
Primary completion
Mar 31, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Oct 12, 2023

Study contacts

Seungsoo Rho, MD, PhD
Contact
harryrho@gmail.com
82-10-9260-3173
Seungsoo Rho, MD, PhD
principal investigator · CHA Bundang Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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