Clinical trial NCT04676854: Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD
Official title: Restoration of Central Vision With the PRIMA System in Patients With Atrophic Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Geographic Atrophy
Lead sponsor: Science Corporation
Sponsor class: INDUSTRY
First posted: 2020-12-21
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Proportion of subjects with meaningful improvement of visual acuity
timeFrame: 12 months
measure: Serious Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of subjects with meaningful improvement of visual acuity
timeFrame: 6, 24, 36 months
measure: Improvement of visual acuity
timeFrame: 6, 12, 24, 36 months
measure: Quality of life measured by IVI
timeFrame: 6, 12, 24, 36 months
measure: Central visual perception
timeFrame: 12 months
measure: Adverse Events
timeFrame: 6, 12, 24, 36 months
measure: Change of natural visual acuity
timeFrame: 6, 12, 24, 36 months
measure: Proportion of compliant implantations
timeFrame: 4 weeks after implantation
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Créteil
country: France
facility: Centre hospitalier intercommunal de Créteil - Service Ophtalmologie
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse CHU de LYON
city: Marseille
country: France
facility: Centre Monticelli Paradis
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hopital des Quinze Vingts
city: Paris
country: France
facility: Fondation Ophtalmologique A. De Rothschild
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, Klinik fuer Augenheilkunde
city: Bonn
country: Germany
facility: Universitäts-Augenklinik Bonn
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Augenklinik
city: Ludwigshafen am Rhein
country: Germany
facility: Klinikum Ludwigshafen -Augenklinik
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
city: Munich
country: Germany
facility: Augenklinik der Ludwig-Maximilian Universität München
city: Münster
country: Germany
facility: Universitäts-Augenklinik Münster
city: Sulzbach/Saar
country: Germany
facility: KNAPPSCHAFTSKLINIKUM SAAR GMBH Augenklinik Sulzbach
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Roma
country: Italy
facility: Università di Roma Tor Vergata - Policlinico Tor Vergata (PTV), Dipartimento di Medicina Sperimentale - Oftalmologia
city: Rotterdam
country: Netherlands
facility: Rotterdam Eye Hospital
state: Schiedamse Vest 160
city: Barcelona
country: Spain
facility: Instituto de Microcirugía Ocular de Barcelona
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
References:
citation: 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.