NCT04796545 Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
| NCT ID | NCT04796545 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VisionCare, Inc. |
| Condition | AMD |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2022-09-13 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2022-09-13 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD). Eligible patients will be implanted with the SING IMT device and will be followed-up for a period of 12-months with post-operative ophthalmic exams and low-vision rehabilitation sessions.
Eligibility Criteria
Inclusion Criteria: 1. Be 55 years of age or older. 2. Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT. 3. Have evidence of cataract. 4. Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes. 5. Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation. 6. Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery when using Samsara's 2.8X external telescope simulator (ETS, supplied separately). 7. Have an ACD of at least 2.5 mm in the eye scheduled for surgery. 8. Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant. 9. Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed. 10. Have adequate understanding of the local language to understand verbal and written subject information and be willing to comply with the study requirements. Exclusion Criteria: 1. Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months. 2. Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye. 3. A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP\>22 mm Hg. 4. Corneal guttata. 5. Known sensitivity to post-operative medications. 6. Significant communication impairment or severe neurological disorders. 7. Have undergone previous intraocular or corneal surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes. 8. An ocular condition that predisposes the patient to eye rubbing. 9. Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery. 10. Patients for whom the planned operative eye has: * Myopia \> 6.0 D * Hyperopia \> 4.0 D * Axial length \< 21 mm * Endothelial cell density \< 1600 cells per square mm * Narrow angle, i.e., \< Schaffer grade 2. 11. Inflammatory ocular disease. 12. Cornea stromal or endothelial dystrophies, including guttata. 13. Zonular weakness/instability of crystalline lens, or pseudoexfoliation. 14. Diabetic retinopathy. 15. Untreated retinal tears. 16. Retinal vascular disease. 17. Optic nerve disease. 18. A history of retinal detachment. 19. Retinitis pigmentosa. 20. Intraocular tumor. 21. Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study. 22. Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative. 23. Have a condition or be in a situation that, in the Investigator's opinion, may put the Subject at significant risk, may confound the study results, or may interfere significantly with the Subject's participation in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04796545 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying AMD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04796545 currently recruiting?
Yes, NCT04796545 is actively recruiting participants. Contact the research team at clinicals@medevise-consulting.com for enrollment information.
Where is the NCT04796545 trial being conducted?
This trial is being conducted at Brussels, Belgium, Marseille, France, Saint-Jean-de-Luz, France, Strasbourg, France and 9 additional locations.
Who is sponsoring the NCT04796545 clinical trial?
NCT04796545 is sponsored by VisionCare, Inc.. The trial plans to enroll 76 participants.