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RecruitingNCT06587945

Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment

A Randomised Double-Masked Placebo-Controlled Trial of Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment

Status
Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
144 (estimated)
Sponsor
Center for Eye Research Australia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Retinal detachment occurs when fluid separates the retina (a thin, light sensing tissue) from its usual attachment at the back of the eye. If detached, these retinal cells lose their normal blood supply and begin to die, which is the primary cause of vision loss in retinal detachment. The 'macula' refers to the very centre of the retina, with the highest density of retinal cells, most responsible for vision. Significant vision loss occurs when this part of the retina becomes separated (termed a 'macula-off retinal detachment'). Typically, surgery is required to repair the retinal detachment. Supporting the health of retinal cells at the macula may prolong their survival after detachment and their recovery postoperatively. Recent evidence has shown that boosting our nicotinamide adenine dinucleotide (NAD+) levels may improve the health of these cells and prolong their survival if detached. Oral Nicotinamide Riboside (NR) is converted into NAD+, and while not studied for macula-off retinal detachments, has been safely used in a range of other conditions. This study is designed to help evaluate the safety and tolerability of NR to help preserve vision in people diagnosed with macula-off retinal detachment. This study drug is given as an oral supplement (tablet) at the time of retinal detachment diagnosis, and daily for 20 weeks thereafter. The drug aims to prolong survival of cells in the retina (and macula) and their recovery after surgery. The long-term goal of this treatment is to reduce loss of vision after retinal detachment. The researchers will compare NR to a placebo (a look-alike substance that contains no drug) to see if NR has a positive effect on photoreceptor survival and quality of vision postoperatively. NR has been approved by the Therapeutic Goods Administration in Australia for many purposes but has not been approved for use in retinal detachment treatment.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTNicotinamide RibosideOral Nicotinamide Riboside, 2g daily for 4 weeks followed by 1g daily for 16 weeks
OTHERPlaceboMatched placebo
PROCEDUREVitrectomy and Gas tamponadeStandard of care Vitrectomy surgery for retinal reattachment

Timeline

Start date
2025-09-19
Primary completion
2027-10-30
Completion
2028-03-30
First posted
2024-09-19
Last updated
2026-03-23

Locations

5 sites across 1 country: Australia

Source: ClinicalTrials.gov record NCT06587945. Inclusion in this directory is not an endorsement.