Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration

Study Overview
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Brief Summary
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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.

Detailed Description
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This is an interventional, prospective, multicenter, open label, single group assignment Post-Market Clinical Follow-up (PMCF) study in men and women >=55 years with central vision impairment associated with end-stage AMD. Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study. Baseline visual acuity of the study subjects will be assessed with a 2.8X external telescope simulator (ETS) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts to determine if they are likely to benefit from receiving the IMT. To be included in the study and to proceed with the surgery, subjects must achieve, using the ETS, at least a one line (5 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery. Subjects not meeting these criteria will be excluded from the study. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Postoperatively, the surgeon will complete a usability and satisfaction questionnaire after each implantation procedure. The patients will undergo ophthalmic evaluations in both eyes at regular intervals for up to 12 months. The subjects will also be required to undergo 6 to 10 additional visits for vision training with a low vision specialist. Surgical complications, as well as all Adverse Event (AEs) and use of medications will be monitored from baseline to the end of the study.

Official Title
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A Prospective, Multicenter Post-marketing Clinical Investigation of the SING IMT(TM) System, Model NG SI IMT 3X in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration

Conditions
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AMD, Age-Related Macular Degeneration

Intervention / Treatment
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* Device: SING IMT(TM) System, model NG SI IMT 3X


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 55 years of age or older. Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT. Have evidence of cataract. 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. Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation. 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). Have an ACD of at least 2.5 mm in the eye scheduled for surgery. Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant. Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed. 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: Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months. Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye. A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP>22 mm Hg. Corneal guttata. Known sensitivity to post-operative medications. Significant communication impairment or severe neurological disorders. 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. An ocular condition that predisposes the patient to eye rubbing. Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery. 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. Inflammatory ocular disease. Cornea stromal or endothelial dystrophies, including guttata. Zonular weakness/instability of crystalline lens, or pseudoexfoliation. Diabetic retinopathy. Untreated retinal tears. Retinal vascular disease. Optic nerve disease. A history of retinal detachment. Retinitis pigmentosa. Intraocular tumor. 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. Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative. 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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: SING IMT(TM) System, model NG SI IMT 3X
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SING IMT System model NG SI IMT 3X<br>All participants will be implanted with the SING IMT System model NG SI IMT 3X. | Device: SING IMT(TM) System, model NG SI IMT 3X<br>* The SING IMT 3X implant is a visual prosthetic implantable device, which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with bilateral, end-stage age-related macular degeneration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the SING IMT System, model NG SI IMT 3X, including its delivery system | The percent decrease in endothelial cell density (ECD). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision size needed for device implantation | Incision size will not exceed 8.0 mm (non-inferiority assumption) in 75% of surgeries | 12 moths | 
| Surgical complications | AEs and serious adverse events | 12 moths | 
| Improvement in near and distance best corrected visual acuity (BCVA) in implanted eyes. | Near and distance BCVA will show an improvement of ≥2 lines in the ETDRS chart in at least 50% (non-inferior to 50%) of the implanted eyes at 12 months post implantation. | 12 months | 
| Usability of SING IMT System, including delivery system | Surgeon will complete a usability and satisfaction questionnaire | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age Related Macular Degeneration, Dry AMD, End-stage age-related macular degeneration, Central vision impairment, Geographic atrophy