Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors

Study Overview
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Brief Summary
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The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.

Detailed Description
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Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.

Official Title
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A Prospective Open Pilot Study With Functional Placebo-control to Evaluate the Efficacy and Tolerability/Safety of a Subretinal Implant in Blind Patients in Accordance With ICH/GCP Guidelines

Conditions
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Retinitis Pigmentosa

Intervention / Treatment
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* Device: Retina implant is surgically placed into subretinal position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hereditary retinal degeneration of the outer retinal layers with the retinal vessels still being perfused and pigments of mild to moderate density Blindness (at least monocular) or visual functions not appropriate for navigation/orientation Period of appropriate visual functions > 12 years / lifetime Visual acuity ≥ 0,05 in earlier life Electrically Evoked Phosphenes provide evidence of inner-retinal function. willing and able to give written informed consent Exclusion Criteria: Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathy, trauma, diabetic retinopathy, retinal detachment) Systemic disease that might imply considerable risk with regard to the surgical intervention and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases) Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression ) Retina detected as too thin (< 100 µm) to expect required rest-functionality as shown via Optical Coherence Tomography (OCT). 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 Participation in another clinical trial within the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1, 2<br>During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active. | Device: Retina implant is surgically placed into subretinal position<br>* Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation & mobility.<br>* Other names: medical device for restoration of vision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY) |  | within implantation period | 
| Patient treatment shows acceptable results (i.e. SAFETY) |  | within implantation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of Daily Living are significantly improved with implant-ON versus OFF, as shown via Tasks of Daily Living test / Orientation & Mobility test (i.e. EFFICACY) |  | within implantation period | 
| Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY) |  | within implantation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Legal blindness, Retinopathy pigmentosa, Hereditary condition, Photo-receptor degeneration, Retina implant, Subretinal implant