Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study (NCT05695027) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study
United States250 participantsStarted 2023-03-14
Plain-language summary
The objective of this study is to determine if a combination of oral nicotinamide and pyruvate (N\&P) can maintain eye health as compared to placebo while standard-of-care intraocular pressure-lowering glaucoma medications are used to treat glaucoma.
A total of up to 188 participants will be enrolled and randomized 1:1 to receive N\&P or placebo for 87 weeks (20 months). Participants will be followed for a total of 91 weeks (21 months).
Who can participate
Age range
35 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to provide informed consent for participation in the study.
. Between 35 and 85 years of age.
. Only one eligible eye per patient will be enrolled. If both eyes qualify, study eye will be elected based on the following characteristics (in order of most to least important): 1) disc hemorrhage, 2) higher intraocular pressure (IOP), 3) without previous filtering surgery, 4) better visual acuity. If both eyes meet these four criteria equally, then the study eye will be determined by random assignment.
. Have a confirmed diagnosis of primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.
. If there is a prior reliable 24-2, the MD should be better than -20dB.
. Able to perform reliable visual field testing with 24-2 Swedish Interactive Threshold Algorithm (SITA)-Standard SAP (defined as false positive rates \<15%, false negative rates \<30%) at the most recent office visit.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in visual field results based on pointwise and global metrics
Timeframe: 87 weeks
2
Change in retinal nerve fiber and ganglion cell layer thickness
. Have best corrected visual acuity better than or equal to 20/40 in the study eye.
. Have an IOP (treated or untreated) ≥ 14 mmHg and within 24 months of the baseline visit and one instance of historical IOP ≥ 16 mmHg by patient report or chart.
Exclusion criteria
. Glaucoma or cataract surgery anticipated in the next 18 months.
. Have a diagnosis of significant cataract or media opacity affecting the visual field test or imaging studies.
. Have a diagnosis of dementia, Alzheimer's, or other neurological disease.
. Have an inability to take or intolerance to nicotinamide and/or pyruvate.
. Have undergone incisional glaucoma surgery (trabeculectomy, glaucoma drainage implant, or Xen Gel Stent) within the last 12 months. Phacoemulsification ± canalicular micro-invasive glaucoma surgery (MIGS) is acceptable if performed ≥ 4 months prior to study entry.
. Prior complicated cataract surgery (e.g., vitrectomy, etc)
. Have a functioning trabeculectomy, glaucoma drainage implant, or Xen Gel Stent (defined as being on 0-1 glaucoma medications). If these surgeries have failed and the patient is on ≥ 2 classes of glaucoma medication and meets all other entry criteria, he/she is eligible).
. Retinal pathology that significantly affects visual acuity (worse than 20/40) or visual field.