Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD
NCT ID: NCT04676854
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
38 participants
INTERVENTIONAL
2020-11-24
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PRIMA Bionic Vision System
PRIMA Bionic Vision System
Implantation of PRIMA, Vision training, follow up
Interventions
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PRIMA Bionic Vision System
Implantation of PRIMA, Vision training, follow up
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
* 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).
60 Years
ALL
No
Sponsors
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Science Corporation
INDUSTRY
Responsible Party
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Locations
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Hôpital Pellegrin
Bordeaux, , France
Centre hospitalier intercommunal de Créteil - Service Ophtalmologie
Créteil, , France
Hôpital de la Croix-Rousse CHU de LYON
Lyon, , France
Centre Monticelli Paradis
Marseille, , France
CHU de Nantes
Nantes, , France
Hopital des Quinze Vingts
Paris, , France
Fondation Ophtalmologique A. De Rothschild
Paris, , France
Universitätsklinikum Aachen, Klinik fuer Augenheilkunde
Aachen, , Germany
Universitäts-Augenklinik Bonn
Bonn, , Germany
Universitätsklinikum Hamburg-Eppendorf (UKE), Augenklinik
Hamburg, , Germany
Klinikum Ludwigshafen -Augenklinik
Ludwigshafen am Rhein, , Germany
Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
Lübeck, , Germany
Augenklinik der Ludwig-Maximilian Universität München
Munich, , Germany
Universitäts-Augenklinik Münster
Münster, , Germany
KNAPPSCHAFTSKLINIKUM SAAR GMBH Augenklinik Sulzbach
Sulzbach, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Università di Roma Tor Vergata - Policlinico Tor Vergata (PTV), Dipartimento di Medicina Sperimentale - Oftalmologia
Roma, , Italy
Rotterdam Eye Hospital
Rotterdam, Schiedamse Vest 160, Netherlands
Instituto de Microcirugía Ocular de Barcelona
Barcelona, , Spain
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Palanker D, Le Mer Y, Mohand-Said S, Muqit M, Sahel JA. Photovoltaic Restoration of Central Vision in Atrophic Age-Related Macular Degeneration. Ophthalmology. 2020 Aug;127(8):1097-1104. doi: 10.1016/j.ophtha.2020.02.024. Epub 2020 Feb 25.
Holz FG, Le Mer Y, Muqit MMK, Hattenbach LO, Cusumano A, Grisanti S, Kodjikian L, Pileri MA, Matonti F, Souied E, Stanzel BV, Szurman P, Weber M, Bartz-Schmidt KU, Eter N, Delyfer MN, Girmens JF, van Overdam KA, Wolf A, Hornig R, Corazzol M, Brodie F, Olmos de Koo L, Palanker D, Sahel JA. Subretinal Photovoltaic Implant to Restore Vision in Geographic Atrophy Due to AMD. N Engl J Med. 2025 Oct 20. doi: 10.1056/NEJMoa2501396. Online ahead of print.
Related Links
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Pixium Vision
Other Identifiers
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CIP-PV-M
Identifier Type: -
Identifier Source: org_study_id