Informations générales (source: ClinicalTrials.gov)
Restoration of Central Vision With the PRIMA System in Patients With Atrophic Age-Related Macular Degeneration (PRIMAvera)
Interventional
N/A
Science Corporation (Voir sur ClinicalTrials)
novembre 2020
février 2028
03 décembre 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Eric SOUIED | 29/03/2024 01:29:21 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Yannick LE MER | 21/06/2024 13:33:57 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHNO DES QUINZE-VINGTS PARIS | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Monticelli Paradis - 13008 - Marseille - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Croix-Rousse CHU de LYON - 69004 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pellegrin - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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).