Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

October 9, 2023 updated by: CHA University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Not provided

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Bundang-gu
      • Seongnam, Bundang-gu, Korea, Republic of, 13497
        • Recruiting
        • CHA University Bundang Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Nicotinamide(VitaminB3)
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
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
Time Frame: Baseline,12weeks
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 12 weeks
Baseline,12weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
Time Frame: Baseline, 6, 12, 18, 24weeks
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks
Baseline, 6, 12, 18, 24weeks
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (Group1 VS Group2)
Time Frame: Baseline, 6, 12, 18, 24weeks
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks
Baseline, 6, 12, 18, 24weeks
Change of mean deviation as measured by Visual Fields (intra-group)
Time Frame: Baseline, 12weeks, 24weeks
Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks
Baseline, 12weeks, 24weeks
Change of mean deviation as measured by Visual Fields (Group1 VS Group2)
Time Frame: Baseline, 12weeks, 24weeks
Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks
Baseline, 12weeks, 24weeks
Change of Pointwise sensitivity as measured by Visual Fields (Group1 VS Group2)
Time Frame: Baseline, 12weeks, 24weeks
Change of Pointwise sensitivity in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total/pattern deviation
Baseline, 12weeks, 24weeks
Change of visual field sensitivity number of locations
Time Frame: Baseline, 12weeks, 24weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHA University

Collaborators

Hanlim Pharm. Co., Ltd.

Investigators

  • Principal Investigator: Seungsoo Rho, MD, PhD, CHA Bundang Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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