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Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

Primary Purpose

Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nicotinamide(Mitovita)
Placebo
Sponsored by
CHA University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Nicotinamide, inner retinal function, retinal ganglion cell functions, Glaucoma, Vitamin B3, NAM, NRG1

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult(Male or Female) over 19 years who were diagnosed with glaucoma. In the case of participants receiving glaucoma treatment drugs, the investigator judges that the intraocular pressure remains constant for at least 1 year. Intraocular pressure (IOP) >/= 8mmHg and < 18mmHg in each eye using Goldmann applanation tonometry prior to the screening visit Adult participants diagnosed and treated for early-moderate glaucoma (VF mean deviation(MD) ≥-12 dB) Have performed a reliable visual field in the last year, with <33% fixation losses, false positives and false negatives. Written consent voluntarily to participate in this clinical trial. Exclusion Criteria: Patients with congenital glaucoma and secondary glaucoma caused by steroid drugs, etc. BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less. Patients who have medical history of ocular inflammation 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.) Patients who have plans to intraocular surgery within the clinical trial period. Patients with a history of significant ocular trauma within 6 months prior to the screening visit Pregnant or lactating women. A person who disagrees to contraception during a clinical trial period. Patients with a history of malignancy within 5 years prior to the screening visit. Patients that other researchers are determined inadequately.

Sites / Locations

  • CHA University Bundang Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nicotinamide(Mitovita)

Placebo

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
February 13, 2023
Last Updated
October 9, 2023
Sponsor
CHA University
Collaborators
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06078605
Brief Title
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHA University
Collaborators
Hanlim Pharm. Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
Detailed Description
Not provided

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Nicotinamide, inner retinal function, retinal ganglion cell functions, Glaucoma, Vitamin B3, NAM, NRG1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nicotinamide(Mitovita)
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Nicotinamide(Mitovita)
Intervention Description
Nicotinamide(VitaminB3)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
Description
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 12 weeks
Time Frame
Baseline,12weeks
Secondary Outcome Measure Information:
Title
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
Description
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
Title
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (Group1 VS Group2)
Description
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
Title
Change of mean deviation as measured by Visual Fields (intra-group)
Description
Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks
Time Frame
Baseline, 12weeks, 24weeks
Title
Change of mean deviation as measured by Visual Fields (Group1 VS Group2)
Description
Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks
Time Frame
Baseline, 12weeks, 24weeks
Title
Change of Pointwise sensitivity as measured by Visual Fields (Group1 VS Group2)
Description
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
Title
Change of visual field sensitivity number of locations
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult(Male or Female) over 19 years who were diagnosed with glaucoma. In the case of participants receiving glaucoma treatment drugs, the investigator judges that the intraocular pressure remains constant for at least 1 year. Intraocular pressure (IOP) >/= 8mmHg and < 18mmHg in each eye using Goldmann applanation tonometry prior to the screening visit Adult participants diagnosed and treated for early-moderate glaucoma (VF mean deviation(MD) ≥-12 dB) Have performed a reliable visual field in the last year, with <33% fixation losses, false positives and false negatives. Written consent voluntarily to participate in this clinical trial. Exclusion Criteria: Patients with congenital glaucoma and secondary glaucoma caused by steroid drugs, etc. BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less. Patients who have medical history of ocular inflammation 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.) Patients who have plans to intraocular surgery within the clinical trial period. Patients with a history of significant ocular trauma within 6 months prior to the screening visit Pregnant or lactating women. A person who disagrees to contraception during a clinical trial period. Patients with a history of malignancy within 5 years prior to the screening visit. Patients that other researchers are determined inadequately.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seungsoo Rho, MD, PhD
Phone
82-10-9260-3173
Email
harryrho@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seungsoo Rho, MD, PhD
Organizational Affiliation
CHA Bundang Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA University Bundang Medical Center
City
Seongnam
State/Province
Bundang-gu
ZIP/Postal Code
13497
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seungsoo Rho, MD, PhD
Phone
+82-10-9260-3173
Email
harryrho@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

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