Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy and safety of the PRIMA System in patients with atrophic AMD. Eligible subjects will be implanted with the PRIMA Implant. The subjects will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical investigation with the PRIMA System (Implant and Visual Processor).

Official Title
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Restoration of Central Vision With the PRIMA System in Patients With Atrophic Age-Related Macular Degeneration

Conditions
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Geographic Atrophy

Intervention / Treatment
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* Device: PRIMA Bionic Vision System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is 60 years or older at the date of inclusion; Has a confirmed diagnosis of geographic atrophy due to AMD in both eyes; The study eye has best corrected visual acuity of logMAR 1.2 (20/320) or worse as measured by ETDRS test; Has an atrophic patch in the study eye including the fovea of at least the implant size (>4.5 mm2 and >2.4 mm in minimum diameter); Understands the constraints of the study and accepts to present for all scheduled follow-up visits; Patient signed informed consent Exclusion Criteria: Has cataract in the study eye (with LOCS III scale NO, NC, C or P>1); (these patients will be asked to have cataract surgery performed prior to enrollment; all other patients will get IOL replacement during the PRIMA implantation); Underwent intra ocular lens implantation in the study eye within the last month ; Has a highly myopic study eye (>26 mm AP); Has a highly hyperopic study eye (<20 mm AP); Has no light perception in either eye; Has a history of documented choroidal neovascularization in either eye; Has any signs of exudative AMD including exudative AMD with detachment of retinal pigment epithelium in the central visual field of the study eye; Has an implanted telescope in one eye; Has a black IOL in the study eye; Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye or the visual system (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, Proliferative Diabetic Retinopathy (PDR), diabetic macular edema (DME), severe Non-Proliferative Diabetic Retinopathy (NPDR), retinal detachment, infectious or inflammatory retinal disease, severe glaucoma, optic neuropathy, etc.) ; Has any disease or condition that prevents adequate examination (including OCT) of the study eye including, but not limited to media opacities that cannot be resolved prior to implantation. Note, that this criterion is also important for the function of the implant; Has a corneal endothelial cell count of less than 1000 cells/mm² in the study eye; Suffers from nystagmus or other ocular motility disorders; Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols (e.g., deafness, severe multiple sclerosis, amyotrophic lateral sclerosis, severe neuritis, etc.); Has epileptic seizures; Has a known sensitivity to the contact materials of the implant (iridium oxide, silicon-carbide and titanium); Has a known allergy to anesthetic drugs; Presents with hypotonia in the study eye (<8 mmHg); Presents with hypertonia in the study eye (>23 mmHg with treatment); Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis; Is an immune-suppressed subject (e.g., due to HIV positive diagnosis, etc.); Is a known carrier of multi-resistant microorganisms; Is receiving anticoagulation therapy that cannot be adapted to allow eye surgery; Is participating in another investigational drug or device study that may interfere with the PRIMAvera study; Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study; Has significant recurrent or chronic inflammations or infections. Specifically, patients with the following disorders are excluded: Severe chronic and consuming diseases that frequently associated with infection (e.g. Crohn disease, Whipple's disease); Active inflammation in the area of the eye (e.g. herpes of cornea and/or conjunctiva, recurrent blepharoconjunctivitis, hordeolum, chalazion); Has a severe psychological disorder; Does not have the mental capacity to legally sign the informed consent; Has severe renal, cardiac, hepatic, etc. organ diseases (ASA IV or worse); Has head dimensions that are incompatible with the PRIMA Glasses; Has a refraction of study eye higher than + 4 dpt or lower than - 4 dpt for patients with IOL (there is no refraction criteria for phakic patients, since they get an IOL during PRIMA implantation); Has too high and/or unrealistic expectations (e.g., believes that a benefit is guaranteed or expects normal vision after surgery). The following additional exclusion criteria are applicable for French subjects: Is a protected person per French law (e.g. is under guardianship, person deprived of their liberty); Is not affiliated to a mandatory social security program (health insurance).

Ages Eligible for Study
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Minimum Age: 60 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRIMA Bionic Vision System<br> | Device: PRIMA Bionic Vision System<br>* Implantation of PRIMA, Vision training, follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with meaningful improvement of visual acuity | Proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 months | 12 months | 
| Serious Adverse Events | Number and severity of device and procedure related serious adverse events at 12 months follow-up | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with meaningful improvement of visual acuity | Proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more at 6, 24 and 36 months compared to baseline | 6, 24, 36 months | 
| Improvement of visual acuity | Mean improvement of visual acuity at 6, 12, 24 and 36 months compared to baseline | 6, 12, 24, 36 months | 
| Quality of life measured by IVI | IVI-Impact of Vision Impairment questionnaire (quality of life based on patient reported outcome of functional vision, participation in vision-related daily living activities and emotional well-being) at 6, 12, 24 and 36 months | 6, 12, 24, 36 months | 
| Central visual perception | Central visual perception with PRIMA at 12 months compared to central visual perception at baseline | 12 months | 
| Adverse Events | Number and severity of procedure and device related adverse events at 6, 12, 24 and 36 months follow-up | 6, 12, 24, 36 months | 
| Change of natural visual acuity | Change of natural visual acuity without the PRIMA Glasses | 6, 12, 24, 36 months | 
| Proportion of compliant implantations | Number of subjects with PRIMA implant placed according protocol | 4 weeks after implantation |