PRIMA US-Feasibility Study in Atrophic Dry AMD

PRIMA is a new photovoltaic sub-retinal wireless prosthesis for partial restoration of visual
perception in patients with vision loss from atrophic dry Age-related Macular Degeneration.
The implantable part of the device is placed under the retina. A mini camera mounted on a
pair of glasses captures the visual scene in the environment. The visual scene is processed
and simplified by the pocket computer connected to the glasses in order to extract useful
information from the images. The simplified images are then sent back to the glasses where a
miniaturized projector then projects the processed images wirelessly via pulses of near
infrared light on the PRIMA implant at the back of the eye under the retina. The photovoltaic
cells convert this optical information into electrical stimulation to excite the nerve cells
of the retina and induce visual perception. In this early feasibility study five human
subjects suffering from atrophic dry age related macular degeneration will receive the
implant. The performance and the safety of the device will be monitored for up to 36 months.

Inclusion Criteria:

- Is 60 years or older at the date of inclusion;

- Has a confirmed diagnosis of atrophic dry age related macular degeneration with an
atrophy size of at least 3 optic disc diameters in the study eye;

- Has best corrected visual acuity of logMAR 1.3 (20/400) or worse in both eyes measured
by ETDRS;

- Has a central scotoma in the study eye with no perception at 0 dB on MP-1
micro-perimetry scale in the visual field covering the central 7 degrees (+/-3.5
degrees) and maximum 20% perception in the remaining visual field covering the central
12 degrees (+/- 6 degrees);

- Has a refraction of study eye between -3 and + 4 (limits included) for patients with
IOL (there is no refraction criteria for phakic patients);

- Understands and accepts the obligation to present for all schedule follow-up visits;

- Patient signed informed consent.

Main Exclusion Criteria:

- Has cataract in the study ;

- Has an aphakic study eye;

- Has no light perception in the study eye;

- Has a history of choroidal neovascularization in either eye;

- Has any disease (other than study allowed diseases) or condition that affects retinal
function of the study eye

- Has an implanted telescope in one eye;

- Has any disease or condition that prevents adequate examination of the study

- 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

- Has a history of epileptic seizure;

- Has a history of chronic or recurrent infection or inflammation that would preclude
participation in the study;

- Presents with hypotony or hypertony in the study eye;

- Has another active implanted device;

- Has active cancer or a history of intraocular, optic nerve or brain cancer and
metastasis;

- Is an immune-suppressed subject;

- Is 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 present study;

- Has recurrent or chronic inflammations or infections;

- 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;

- Has head dimensions that are incompatible with the Visual Interface;

- Has too high and unrealistic expectation;

Detailed patient criteria will be verified by the study doctor.