Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06587945

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

Led by Center for Eye Research Australia · Updated on 2026-03-23

144

Participants Needed

5

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Retinal detachment happens when the retina, the thin tissue at the back of the eye that senses light, separates from its normal position. This causes retinal cells to lose blood supply and start dying, leading to vision loss. The central part of the retina, called the macula, is crucial for sharp vision. When the macula detaches, significant vision loss occurs. This trial evaluates Nicotinamide Riboside (NR), a supplement that may help protect retinal cells and improve vision recovery after surgery for macula-off retinal detachment. NR has been used safely in other conditions but not yet studied for this eye problem. Participants take oral Nicotinamide Riboside starting at diagnosis: 2 grams daily for 4 weeks, then 1 gram daily for 16 weeks after retinal reattachment surgery. The study compares this supplement to a placebo to see if NR helps the retinal cells survive and improves vision after surgery. Standard vitrectomy and gas tamponade surgery will be performed as part of usual care. During the 20-week study period, participants will have their vision tested including best-corrected visual acuity, microperimetry, and contrast sensitivity. Eye scans will check the photoreceptor layer's condition. Safety, tolerability, and vision outcomes will be closely monitored. The study is randomized and double-masked to fairly compare NR and placebo effects in people with macula-off retinal detachment.

CONDITIONS

Brief Title

Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • 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 loss of central vision
  • Visual acuity of hand motion or better in the study eye
  • Previous cataract surgery in the study eye
  • Clinical indication for standard retinal reattachment surgery by pars plana vitrectomy and gas tamponade
  • Investigator's opinion of ability to safely undergo all study procedures
Not Eligible

You will not qualify if you...

  • Significant ocular disease in the study eye that could limit visual acuity to less than 6/7.5 (20/25) or visibility of the retina
  • Other ocular pathology in the study eye requiring treatment with topical drops or intravitreal injection
  • Previous ocular surgery in the study eye other than uncomplicated cataract surgery or refractive surgery within 3 months prior to baseline
  • Participation in other clinical trials or use of investigational drugs/devices within 3 months prior to study
  • Females who are pregnant, lactating, or women of childbearing potential
  • Known retinopathy, hepatic disease, or renal disease (patients with diabetes but no retinopathy may be enrolled)
  • History of uncontrolled hypertension
  • History of stroke, transient ischemic attack, major cardiac surgery within 3 months prior, or current systemic infection treatment
  • Any ocular or systemic condition that may compromise safety or interfere with study assessments according to investigator opinion

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo standard retinal reattachment surgery using pars plana vitrectomy and gas tamponade.

1 visit (in-person)

Treatment

Duration - 4 weeks at 2g daily followed by 16 weeks at 1g daily

Participants take oral Nicotinamide Riboside or matched placebo daily, starting from the date of presentation and continuing postoperatively.

Regular visits during the 20-week treatment period

Post-operative Follow-up

Duration - Up to 20 weeks postoperatively

Participants are monitored postoperatively for visual acuity, microperimetry, contrast sensitivity, and retinal integrity.

Multiple follow-up visits during the 20 weeks

Trial Site Locations

Total: 5 locations

1

Centre for Eye Research Australia

East Melbourne, Victoria, Australia, 3002

Actively Recruiting

2

Cerulea

East Melbourne, Victoria, Australia, 3002

Actively Recruiting

3

The Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, Australia, 3002

Actively Recruiting

4

Dr David Fabinyi

Geelong, Victoria, Australia, 3220

Actively Recruiting

5

Dr David Sousa

Geelong, Victoria, Australia, 3220

Actively Recruiting

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Research Team

C

Carly Parfett

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults.

Christopher R Martens, Blair A Denman, Melissa R Mazzo...

https://pubmed.ncbi.nlm.nih.gov/29599478

Systemic Treatment With Nicotinamide Riboside Is Protective in a Mouse Model of Light-Induced Retinal Degeneration.

Xian Zhang, Nathaniel F Henneman, Preston E Girardot...

https://pubmed.ncbi.nlm.nih.gov/32852543