Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment

Launched by CENTER FOR EYE RESEARCH AUSTRALIA · Sep 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of an oral supplement called Nicotinamide Riboside (NR) on patients with a specific type of eye condition known as macula-off retinal detachment. This condition occurs when the retina, especially the central part responsible for sharp vision, gets separated from the back of the eye, potentially leading to serious vision loss. The researchers want to see if taking NR can help protect and support the health of the cells in the retina after detachment and surgery, with the hope of improving vision recovery.

To participate in this study, individuals must be at least 18 years old and diagnosed with macula-off retinal detachment within 10 days of noticing vision changes. Participants will need to be able to attend study visits and follow the procedures. Those who join will take the NR supplement daily for 20 weeks, starting from the time of their diagnosis. The study will also compare the effects of NR with a placebo (a substance with no active drug) to determine if NR truly helps improve vision after surgery. It's important to note that while NR is approved for other uses in Australia, it has not yet been approved specifically for treating retinal detachment.

Gender

ALL

Eligibility 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.