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

  • STATUS
    Recruiting
  • End date
    Nov 24, 2026
  • participants needed
    38
  • sponsor
    Pixium Vision SA
Updated on 5 August 2021
geographic atrophy
corrected visual acuity
atrophy
vision test

Summary

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).

Details
Condition Dry Macular Degeneration, age-related macular degeneration, Macular Degeneration, Geographic Atrophy
Treatment PRIMA Bionic Vision System
Clinical Study IdentifierNCT04676854
SponsorPixium Vision SA
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

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/mm 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)
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