Oral nicotinamide riboside to protect the macula after retinal detachment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.