Restoration of central vision with the PRIMA System in Patients with Atrophic Age-Related Macular Degeneratio
- Conditions
- Age-related macular degenerationAMDGeographic Atrophy10047518
- Registration Number
- NL-OMON54164
- Lead Sponsor
- Pixium Vision SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
A subject will be included in the study provided he or she:
• 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 (>4.5mm^2 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.
A subject will be excluded from the study if he or she:
• 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, siliconcarbide 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is the assessment of visual acuity improvement at<br /><br>12 months after implantation of subjects provided with the PRIMA System<br /><br>compared to visual acuity at baseline.<br /><br>Specifically, the endpoint will assess the proportion of subjects who have an<br /><br>improvement of logMAR 0.2 (10 letters/ equivalent to 2 lines) or more at 12<br /><br>months after implantation compared to baseline.<br /><br>The primary safety endpoint involves an analysis of the incidence and severity<br /><br>of all device or procedure related serious adverse events during the follow-up<br /><br>period of 12 months. The safety of the implanted device will be assessed in a<br /><br>series of regular ophthalmological examinations designed to capture any<br /><br>pathological changes in the eye as a result of device implantation.</p><br>
- Secondary Outcome Measures
Name Time Method