Status:
NOT_YET_RECRUITING
Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment
Lead Sponsor:
Center for Eye Research Australia
Conditions:
Retinal Detachment
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 supp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06587945
Start Date
May 1 2025
End Date
November 30 2027
Last Update
February 24 2025
Active Locations (5)
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1
Centre for Eye Research Australia
East Melbourne, Victoria, Australia, 3002
2
Cerulea
East Melbourne, Victoria, Australia, 3002
3
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia, 3002
4
Dr David Fabinyi
Geelong, Victoria, Australia, 3220