Retinal DetachmentPhase 4NOMADNCT06587945
Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment
A Phase 4 study testing Nicotinamide Riboside and Vitrectomy and Gas tamponade in people with Retinal Detachment, run by Center for Eye Research Australia at 5 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Nicotinamide Riboside and Vitrectomy and Gas tamponade
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 5 sitesAustralia
- Study dates
- 19 Sep 2025to 30 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Recruiting
Centre for Eye Research Australia
East Melbourne, Victoria, 3002
Carly Parfett, +61 03 9959 0028, cera-rgo@cera.org.au
- Recruiting
Cerulea
East Melbourne, Victoria, 3002
Flora Hui, +61 3 9959 0068, fhui@cera.org.au
- Recruiting
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 3002
David Sousa, MD PhD FRANZCO, +61 03 9929 8666, david.sousa@eyeandear.org.au
David Sousa
- Recruiting
Dr David Fabinyi
Geelong, Victoria, 3220
David Fabinyi, MBBS FRANZCO, +61 419 157 350, fabinyireception@gmail.com
- Recruiting
Dr David Sousa
Geelong, Victoria, 3220
David Sousa, MD PhD FRANZCO, +61 3 5229 6300, sousa.sjog@gmail.com
David Sousa
About this study
Official title: A Randomised Double-Masked Placebo-Controlled Trial of Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment
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.
Read more
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
- Retinal Detachment
- Being tested
- Nicotinamide Riboside, Placebo, Vitrectomy and Gas tamponade
- Keywords
- Nicotinamide Riboside, Retinal detachment, Photoreceptors, Macula-off, Vitrectomy
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide RibosideDietary supplement
Oral Nicotinamide Riboside, 2g daily for 4 weeks followed by 1g daily for 16 weeks
PlaceboOther
Matched placebo
Vitrectomy and Gas tamponadeProcedure or surgery
Standard of care Vitrectomy surgery for retinal reattachment
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide Riboside | Experimental | Oral Nicotinamide Riboside intake from date of presentation: 2g daily for 4 weeks followed by 1g daily for 16 weeks postoperatively Receives: Dietary Supplement: Nicotinamide Riboside; Procedure: Vitrectomy and Gas tamponade |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo; Procedure: Vitrectomy and Gas tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected Visual Acuity
Measured: 20 weeks postoperatively
Microperimetry
Measured: 20 weeks postoperatively
Contrast sensitivity
Measured: 20 weeks postoperatively
Secondary outcomes (1)
Integrity of the photoreceptor layer on optical coherence tomography
Measured: 20 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Sep 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre participant- and assessor-masked placebo-controlled randomised superiority trial with two parallel groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Eye Research Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Sousa, MD PhD FRANZCO, Principal investigator, Center for Eye Research Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587945
- Sponsor's protocol ID
- NOMAD
- Other IDs
- U1111-1307-8530
- Acronym
- NOMAD
- Status last verified
- Mar 2026
- First submitted
- 5 Sep 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martens CR, Denman BA, Mazzo MR, Armstrong ML, Reisdorph N, McQueen MB, Chonchol M, Seals DR. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. Nat Commun. 2018 Mar 29;9(1):1286. doi: 10.1038/s41467-018-03421-7.
PubMed 29599478Chen AC, Martin AJ, Choy B, Fernandez-Penas P, Dalziell RA, McKenzie CA, Scolyer RA, Dhillon HM, Vardy JL, Kricker A, St George G, Chinniah N, Halliday GM, Damian DL. A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention. N Engl J Med. 2015 Oct 22;373(17):1618-26. doi: 10.1056/NEJMoa1506197.
PubMed 26488693Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948.
PubMed 27721479Bai S, Sheline CT. NAD(+) maintenance attenuates light induced photoreceptor degeneration. Exp Eye Res. 2013 Mar;108:76-83. doi: 10.1016/j.exer.2012.12.007. Epub 2012 Dec 26.
PubMed 23274583Zhang X, Henneman NF, Girardot PE, Sellers JT, Chrenek MA, Li Y, Wang J, Brenner C, Nickerson JM, Boatright JH. Systemic Treatment With Nicotinamide Riboside Is Protective in a Mouse Model of Light-Induced Retinal Degeneration. Invest Ophthalmol Vis Sci. 2020 Aug 3;61(10):47. doi: 10.1167/iovs.61.10.47.
PubMed 32852543
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-Masked Placebo-Controlled Trial of Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment
- ClinicalTrials.gov ID
- NCT06587945
- Acronym / sponsor ID
- NOMAD / NOMAD
- Conditions
- Retinal Detachment
- Keywords
- Nicotinamide Riboside, Retinal detachment, Photoreceptors, Macula-off, Vitrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Center for Eye Research AustraliaUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-centre participant- and assessor-masked placebo-controlled randomised superiority trial with two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide Riboside | Experimental | Dietary Supplement: Nicotinamide Riboside, Procedure: Vitrectomy and Gas tamponadeOral Nicotinamide Riboside intake from date of presentation: 2g daily for 4 weeks followed by 1g daily for 16 weeks postoperatively |
| Placebo | Placebo comparator | Other: Placebo, Procedure: Vitrectomy and Gas tamponade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide RibosideOral Nicotinamide Riboside, 2g daily for 4 weeks followed by 1g daily for 16 weeks | Dietary supplement | Nicotinamide Riboside |
| PlaceboMatched placebo | Other | Placebo |
| Vitrectomy and Gas tamponadeStandard of care Vitrectomy surgery for retinal reattachment | Procedure or surgery | Nicotinamide Riboside, Placebo |
Primary outcome
Best-corrected Visual Acuity
Time frame: 20 weeks postoperatively
Microperimetry
Time frame: 20 weeks postoperatively
Contrast sensitivity
Time frame: 20 weeks postoperatively
1 secondary outcome
Integrity of the photoreceptor layer on optical coherence tomography
Time frame: 20 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 29599478Martens CR, Denman BA, Mazzo MR, Armstrong ML, Reisdorph N, McQueen MB, Chonchol M, Seals DR. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. Nat Commun. 2018 Mar 29;9(1):1286. doi: 10.1038/s41467-018-03421-7.
- Background: PubMed 26488693Chen AC, Martin AJ, Choy B, Fernandez-Penas P, Dalziell RA, McKenzie CA, Scolyer RA, Dhillon HM, Vardy JL, Kricker A, St George G, Chinniah N, Halliday GM, Damian DL. A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention. N Engl J Med. 2015 Oct 22;373(17):1618-26. doi: 10.1056/NEJMoa1506197.
- Background: PubMed 27721479Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948.
- Background: PubMed 23274583Bai S, Sheline CT. NAD(+) maintenance attenuates light induced photoreceptor degeneration. Exp Eye Res. 2013 Mar;108:76-83. doi: 10.1016/j.exer.2012.12.007. Epub 2012 Dec 26.
- Background: PubMed 32852543Zhang X, Henneman NF, Girardot PE, Sellers JT, Chrenek MA, Li Y, Wang J, Brenner C, Nickerson JM, Boatright JH. Systemic Treatment With Nicotinamide Riboside Is Protective in a Mouse Model of Light-Induced Retinal Degeneration. Invest Ophthalmol Vis Sci. 2020 Aug 3;61(10):47. doi: 10.1167/iovs.61.10.47.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Sousa, MD PhD FRANZCO principal investigator
Center for Eye Research Australia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotinamide Riboside and Vitrectomy and Gas tamponade in people with Retinal Detachment, run by Center for Eye Research Australia at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carly Parfett (+61399590028, cera-rgo@cera.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected Visual Acuity (time frame: 20 weeks postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06587945, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.