RETINA IMPLANT Alpha AMS in Blind Patients With Retinitis Pigmentosa

Retinitis Pigmentosa (RP) is a rare genetic disorder albeit the most common cause of
inherited blindness. With progressive loss of function and cells in the outer retina,
individuals with RP can progress to complete blindness of Light Perception or No Light
Perception. There is no known cure or treatment for RP individuals at the Light Perception or
No Light Perception phase of this progressive degenerative disease. The RETINA IMPLANT Alpha
AMS is an investigational device designed to restore limited visual function and functional
vision in this subset of patients suffering with RP whose visual acuity has deteriorated to
the level of Light Perception or No Light Perception.

The RETINA IMPLANT Alpha AMS has been designed to replace the non-functioning and absent
photoreceptor cells with a functional device to stimulate the remaining components of the
retina to restore limited visual function and functional vision in patients with RP. The
RETINA IMPLANT Alpha AMS device is surgically implanted subretinally to replace the
non-functioning pathologic photoreceptor/RPE layer (or absent photoreceptor cells and
defective pigment epithelium). The focusing lens system of the eye directs the visual image
onto the device. When turned "ON" the device then stimulates the remaining visual cells of
the inner layers of the retina and this visual information is subsequently transmitted by the
remaining retinal network via the optic nerve to the visual cortex in the Central Nervous
System (CNS).

This investigation is an Early Feasibility Study and will seek to implant five (5) to eight
(8) patients. One surgical team, highly experienced in similar vitreoretinal procedures will
be trained and will implant the enrolled patients. Follow-up visits for each patient will
include an evaluation of safety and effectiveness at various time periods with follow-up
continuing through five (5) years.

The use of masking in this clinical trial will be employed at the level of implanted subjects
undergoing effectiveness evaluations during the follow-up visits as further described.
Implant "ON" and "OFF" modality will be randomized and unknown to each subject undergoing
functional vision tests during the follow-up visit. The "ON" and "OFF" will be encoded as
either mode-1 or mode-2; for each test run, mode-1 and mode-2 will be differently encoded.
The subject's visual performance will be evaluated and recorded for both "ON" and "OFF"
implant conditions.

Each potential subject will undergo screening and evaluation to document that the eligibility
criteria have been met and for proper surgical planning for implantation of the RETINA
IMPLANT Alpha AMS. Qualifying subjects will undergo surgical implantation of the RETINA
IMPLANT Alpha AMS in one eye and will be followed immediately in the post-operative period.
Follow-up will continue for five (5) years.

Inclusion Criteria:

• Blind RP patients with LP or NLP identified in both eyes using a photoflash test.

(NLP inclusion is defined as participants who at screening give less than 9 correct answers
out of 20 trials to the photoflash test; LP inclusion is defined as participants who at
screening give 9 or more correct answers out of 20 trials to the photoflash test)

- Pseudophakia for at least 3 months prior to entrance into study.

- Central visual function of 12 years / lifetime or greater with a history of reading
vision in the eye to be implanted.

- Fluorescein angiography showing retinal vascular perfusion in all four quadrants of
macula.

- Fifty (50) years of age or older at time of enrollment.

- Evidence of inner retinal function (ganglion cells and optic nerve function) by EEP
test identified by the ability to elicit phosphene thresholds.

- ERG showing rod and cone non-function.

- Willing and able to give written informed consent and participate in ongoing
follow-up.

Exclusion Criteria:

- Ophthalmic conditions other than RP with relevant effect upon visual function (e.g.,
glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment,
macular degeneration, cystoid macular edema, MS) with the addition of tobacco, alcohol
abuse and retinotoxic drugs e.g. plaquenil and thorazine.

- Any other ocular disease that affects retina and / or optic nerve function.

- Opacification of ocular structures that prevent clear image transmission.

- Nystagmus.

- Cystoid macular edema within target region for implantation shown via Optical
Coherence Tomography (OCT).

- Retina detected as too thin as shown via OCT (<100 μm) to expect required
functionality of inner retina and /or OCT shows no layering of the inner retina in the
central region.

- Scar tissue (e.g., epiretinal, intraretinal, subretinal, macular pucker) within target
region for implantation.

- Heavily clumped pigmentation at posterior pole (would interfere with image
transmission to vision chip).

- Anterior segment pathology that interferes with clear visualization of the retina
(e.g., presence of cloudy or scarred cornea and / or papillary membrane) that cannot
be resolved prior to entrance into study.

- Amblyopia reported earlier in life for eye to be implanted.

- Systemic diseases that might imply considerable risks with regard to the surgical
interventions and anesthesia (e.g., cardiovascular / pulmonary diseases, severe
metabolic diseases).

- Any condition and / or allergic contraindication to pre-operative, intra-operative,
and post-operative medication.

- Health problems where general anesthesia is contraindicated.

- Disease or conditions that would probably limit life expectancy to less than 1 year
from screening.

- Orbital deformity that would interfere with surgical implantation that could not be
resolved prior to entrance into study.

- Patients with plastic intra-ocular lenses, or other materials, that would interact
with silicone oil.

- Women who are pregnant or nursing, or women of childbearing potential who are not
willing to use a medically acceptable means of birth control for the duration of the
study, or women unwilling to perform a pregnancy test before entering the study.

- Neurological and / or psychiatric diseases (e.g., Parkinson, epilepsy, MS, depression
or severe anxiety).

- Lack of cognitive and / or emotional ability (e.g., depression or severe anxiety)
limiting participation as assessed by psychiatric evaluation.

- Participation in another interventional clinical trial within the past 30 days.

- The need for regular administration of anticoagulants, platelet aggregation inhibitors
or analgesics containing acetylsalicylic acid.

- Disease or conditions that likely require regular use of MRI or other similar imaging
technology that emits electromagnetic radiation.

- Patients unwilling to avoid participating in vigorous sports or activities with a high
risk of a head injury.

- Patients unwilling to avoid security-scanning devices that would result in a full
body, manual search.

- Ability to perceive form or motion under optimal conditions (largest size, brightest
lighting, highest contrast, etc.) of form and motion testing as tested by BaLM, BaGA,
and Landolt C.

- Patients with hearing deficits and cochlear implants or patients who may be implanted
with cochlear implants in the near future.

- Patients undergoing or requiring medical treatments generating induced currents in the
area of the implant such as electrosurgery, diathermy, neurostimulation,
electroconvulsive therapy, ionizing radiation therapy, therapeutic ultrasound.

- Subjects with no active immunization status against organisms causing meningitis.