Oral nicotinamide riboside to protect the macula after retinal detachment
A Randomised Double-Masked Placebo-Controlled Trial of Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment
This will test whether taking oral nicotinamide riboside around the time of surgery helps preserve central vision in adults with a macula-off retinal detachment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Center for Eye Research Australia Academic / other |
| Locations | 5 sites (East Melbourne, Victoria and 4 other locations) |
| Trial ID | NCT06587945 on ClinicalTrials.gov |
What this trial studies
Adults who present within 10 days with a macula-off retinal detachment and meet eligibility criteria will undergo standard pars plana vitrectomy with gas tamponade and be given either oral nicotinamide riboside or a matching placebo. Nicotinamide riboside is a supplement that is converted into NAD+, and preclinical work suggests higher NAD+ levels can improve photoreceptor survival after detachment. The trial compares postoperative visual recovery and retinal structure between the treatment and placebo groups. Safety and tolerability of perioperative NR dosing will also be monitored.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) who present within 10 days of a macula-off retinal detachment, have prior cataract surgery in the study eye, have visual acuity of hand motion or better, and are suitable for pars plana vitrectomy with gas tamponade.
Not a fit: Patients with other significant ocular disease (for example corneal opacity), additional eye conditions needing topical or intravitreal treatment, or those presenting more than 10 days after symptom onset are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this could help preserve central retinal cells and improve visual recovery after surgery for macula-off retinal detachment.
How similar studies have performed: Preclinical studies and some early clinical work on NAD+-boosting therapies suggest improved photoreceptor survival, but oral nicotinamide riboside has not previously been tested specifically for macula-off retinal detachment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Able to give informed consent and comply with all study visits and procedures. * Present within 10 days of macula-off retinal detachment (based on patient-reported history of loss of central vision) * Present to the hospital with a visual acuity of hand motion or better in the study eye * Have had previous cataract surgery in the study eye * Have clinical indication for standard retinal reattachment surgery by means of a pars plana vitrectomy and gas tamponade * In the opinion of the investigator, be able to safely undergo all study procedures. Key exclusion Criteria: * Any known significant ocular disease in the study eye (e.g., cornea opacity) which, in the opinion of the investigator, would preclude a visual acuity of at least 6/7.5 (20/25) following successful vitrectomy or limit adequate visibility of the retina. * Any other ocular pathology in the study eye requiring treatment with topical ophthalmic drops or intravitreal injection. * History of previous ocular surgery in the study eye other than uncomplicated cataract surgery with posterior chamber intraocular lens and intact posterior capsule or a refractive surgery (surgery must have occurred at least 3 months prior to the baseline visit). * Participation in other clinical trials or use of any other investigational drugs or devices within 3 months prior to study participation. * Females who are pregnant or lactating and women of childbearing potential. * Known retinopathy, known hepatic disease (or history of significant chronic liver disease), or known renal disease. Patients Participants with diabetes and no known retinopathy may be enrolled. * History of uncontrolled hypertension. * History of stroke, transient ischemic attack, or major cardiac surgery within 3 months prior to study, or current treatment for systemic infection. * Any ocular or systemic condition that in the opinion of the investigator could compromise the safety of the patientparticipant, or may interfere with the safety and tolerability assessments or study procedures of the trial.
Where this trial is running
East Melbourne, Victoria and 4 other locations
- Centre for Eye Research Australia — East Melbourne, Victoria, Australia (Recruiting)
- Cerulea — East Melbourne, Victoria, Australia (Recruiting)
- The Royal Victorian Eye and Ear Hospital — East Melbourne, Victoria, Australia (Recruiting)
- Dr David Fabinyi — Geelong, Victoria, Australia (Recruiting)
- Dr David Sousa — Geelong, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: David Sousa, MD PhD FRANZCO — Center for Eye Research Australia
- Study coordinator: Carly Parfett
- Email: cera-rgo@cera.org.au
- Phone: +61399590028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.